Obinutuzumab with or without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients with Relapsed or Refractory Grade I-IIIa Follicular Lymphoma

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Status: Active

Description

This randomized phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of the tumor cells to grow and spread. Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma.

Eligibility Criteria

Inclusion Criteria

  • Patients must have follicular lymphoma (grade I, II or IIIa) confirmed at initial diagnosis and at relapse with identifiable fludeoxyglucose F-18 (FDG) avid disease on PET/CT; patients that have involvement with large cell lymphoma are not eligible
  • Patients must not have clinical evidence of central nervous system involvement by lymphoma since the proposed treatment strategies are not designed to address central nervous system (CNS) involvement adequately; if performed, any laboratory or radiographic tests performed to assess CNS involvement must be negative
  • Patients must have a whole body or limited whole body PET/CT scan performed within 42 days prior to registration
  • Patients must have bone marrow biopsy performed within 42 days prior to registration
  • All disease must be assessed and documented on the S1608 FDG-PET/CT assessment form
  • Patients must have either failed to achieve a complete remission, or must have relapsed within 2 years after completing CHOP or bendamustine-containing chemoimmunotherapy (including an anti-CD20 monoclonal antibody), as measured from the last dose of CHOP or bendamustine; relapsed patients must not have received any intervening chemotherapy; patients must have received only 1 course of chemotherapy, containing at least 3 cycles of CHOP or bendamustine; (note that no minimum dose of bendamustine is required); patients who received any anti-CD20 antibody therapy prior to CHOP or bendamustine are eligible; patients who additionally received any maintenance anti-CD-20 antibody therapy or consolidative radioimmunotherapy within 2 years of the last dose of the CHOP or bendamustine therapy are eligible; involved field or involved site radiation is not considered a line of therapy; examples of eligible prior treatment regimens (note this list is not all inclusive): * 1st line rituximab treatment followed years later by bendamustine rituximab x 4 cycles * Bendamustine rituximab x 4 cycles * 1st line rituximab treatment, 2nd line ibritumomab tiuxetan, followed by bendamustine bortezomib rituximab x 6 cycles followed by rituximab maintenance * Bendamustine obinutuzumab x 3 cycles * CHOP rituximab x 6 cycles followed by rituximab maintenance
  • For all forms of systemic therapy, patients must have completed therapy at least 21 days prior to registration; patients must have completed any radioimmunotherapy at least 84 days prior to registration; patients must have recovered from all treatment related toxicities from these therapies prior to registration
  • Patients must not have any prior treatment with any PI3K inhibitor, or lenalidomide
  • Patients must have tissue specimens collected prior to registration; patients must be offered participation in biobanking of residual specimens; with patient consent, residuals from the mandatory submission will be banked for future research
  • All patients must have a Zubrod performance status of 0, 1 or 2
  • Absolute neutrophil count (ANC) >= 1,500/mcL within 28 days prior to registration
  • Platelets >= 75,000/mcL within 28 days prior to registration
  • Patients must have adequate renal function as documented by a calculated creatinine clearance >= 60 mL/min, within 28 days prior to registration
  • Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (=< 5 x IULN if secondary to lymphoma, Gilbert’s syndrome, or medication related [e.g., indinavir, tenofovir, atazanavir]) within 28 days prior to registration
  • Direct bilirubin =< 1.5 x IULN (=< 5 x IULN if secondary to lymphoma) within 28 days prior to registration
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (=< 5 x IULN secondary to lymphoma) within 28 days prior to registration
  • Patients must have an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 42 days prior to registration with a cardiac ejection fraction >= 45%
  • Patients with hepatitis B virus infection must have undetectable hepatitis B virus (HBV) on suppressive therapy and no evidence of HBV-related hepatic damage; patients with hepatitis C virus infection are eligible if complete eradication therapy has been successfully completed, and there is no detectable hepatitis C virus (HVC) or related hepatic damage; patients with known human immunodeficiency virus (HIV) infection are eligible if they meet all of the following criteria in addition to the other protocol eligibility criteria: * Patient must have no history of acquired immune deficiency syndrome (AIDS)-related complications, other than a history of low CD4+ T-cell count (< 200/mm^3) prior to initiation of combination antiretroviral therapy; on study CD4+ T-cell count may not be informative due to leukemia and should not be used as an exclusion criterion if low * Patient must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the leukemia * Patient must have serum HIV viral load of < 200 copies/mm^3 * Patient must be on combination antiretroviral therapy with minimal pharmacokinetic interactions with study therapy and minimal overlapping clinical toxicity with protocol therapy; (recommend a regimen of the integrase inhibitor dolutegravir combined with either disoproxil fumarate/emtricitabine or dolutegravir combined with tenofovir alafenamide/emtricitabine) * Protease inhibitors and once daily formulations containing cobicistat are NOT allowed due to potential pharmacokinetic interactions with leukemia therapy * Stavudine and zidovudine (AZT) are NOT allowed because of overlapping toxicity with protocol therapy
  • Patients must be able and willing to receive prophylaxis with daily aspirin, low molecular weight heparin, factor X inhibitors or warfarin if randomized to lenalidomide; patients must also be willing to receive pneumocystis jirovecii prophylaxis with sulfamethoxazole/trimethoprim, dapsone, atovaquone or inhaled pentamidine, in the event that they are randomized to TGR-1202; patients unable or unwilling to take any listed prophylaxis are NOT eligible
  • Patients must be able to discontinue CYP2C9 substrates with a narrow therapeutic index (e.g. warfarin, phenytoin), if randomized to TGR-1202; patients must discontinue such agents at least 1 week or 5 half-lives prior to beginning protocol therapy (whichever is longer)
  • No second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for three years
  • Patients must have a complete history and physical examination within 28 days prior to registration
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; further, they must either commit to complete abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence [e.g., calendar, ovulation, symptothermal or post ovulation methods] and withdrawal are not acceptable methods of contraception) from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; while taking lenalidomide, during dose interruptions, and for at least 28 days after the last dose of lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a female who: 1) has achieve menarche at some point; 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure; NOTE: patients not randomized to receive lenalidomide will not be required to undergo serial pregnancy testing or lenalidomide counseling after registration
  • Patients must have lactate dehydrogenase (LDH) and beta-2-microglobulin collected within 28 days prior to registration
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Locations & Contacts

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Oncology and Hematology LLC
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Women's Cancer Care
Status: Active
Contact: Site Public Contact
Email: protocols@swog.org
Anchorage Oncology Centre
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Katmai Oncology Group
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Providence Alaska Medical Center
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org

Arizona

Tucson
The University of Arizona Medical Center-University Campus
Status: Active
Contact: Site Public Contact
Phone: 520-626-9008
University of Arizona Cancer Center-North Campus
Status: Active
Contact: Site Public Contact
Phone: 800-327-2873

California

Anaheim
Kaiser Permanente-Anaheim
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Auburn
Sutter Auburn Faith Hospital
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Baldwin Park
Kaiser Permanente-Baldwin Park
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Bellflower
Kaiser Permanente-Bellflower
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 818-847-4793
Email: Madonna.Johnson@providence.org
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org
Fontana
Kaiser Permanente-Fontana
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Harbor City
Kaiser Permanente - Harbor City
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Irvine
Kaiser Permanente-Irvine
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Loma Linda
Loma Linda University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 909-558-3375
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Kaiser Permanente-Cadillac
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Modesto
Memorial Medical Center
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Mountain View
Palo Alto Medical Foundation-Camino Division
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Palo Alto Medical Foundation-Gynecologic Oncology
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Palo Alto
Palo Alto Medical Foundation Health Care
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Panorama City
Kaiser Permanente - Panorama City
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Rancho Mirage
Eisenhower Medical Center
Status: Active
Contact: Site Public Contact
Phone: 760-834-3798
Sacramento
Sutter Medical Center Sacramento
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
San Diego
Kaiser Permanente-San Diego Mission
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Kaiser Permanente-San Diego Zion
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
San Francisco
California Pacific Medical Center-Pacific Campus
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
San Marcos
Kaiser Permanente-San Marcos
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org
Santa Cruz
Palo Alto Medical Foundation-Santa Cruz
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Santa Rosa
Sutter Pacific Medical Foundation
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Sunnyvale
Palo Alto Medical Foundation-Sunnyvale
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Woodland Hills
Kaiser Permanente-Woodland Hills
Status: Active
Contact: Site Public Contact
Phone: 800-398-3996
Email: clinical.trials@kp.org

Colorado

Aurora
Rocky Mountain Cancer Centers-Aurora
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Boulder
Boulder Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: jbloomfield@co-cancerresearch.org
Rocky Mountain Cancer Centers-Boulder
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Colorado Springs
Penrose-Saint Francis Healthcare
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Rocky Mountain Cancer Centers-Penrose
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Denver
Colorado Blood Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Denver Health Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Porter Adventist Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Presbyterian - Saint Lukes Medical Center - Health One
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Rocky Mountain Cancer Centers-Midtown
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Rocky Mountain Cancer Centers-Rose
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Rose Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
SCL Health Saint Joseph Hospital
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Durango
Mercy Medical Center
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Englewood
Comprehensive Cancer Care and Research Institute of Colorado LLC
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Swedish Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Golden
Mountain Blue Cancer Care Center
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Grand Junction
Saint Mary's Hospital and Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Greeley
North Colorado Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Greenwood Village
Rocky Mountain Cancer Centers-Greenwood Village
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Lakewood
Rocky Mountain Cancer Centers-Lakewood
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Saint Anthony Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Littleton
Littleton Adventist Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Rocky Mountain Cancer Centers-Littleton
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Longmont
Longmont United Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Rocky Mountain Cancer Centers-Longmont
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Loveland
McKee Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Parker
Parker Adventist Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Rocky Mountain Cancer Centers-Parker
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Pueblo
Saint Mary Corwin Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Thornton
Rocky Mountain Cancer Centers-Thornton
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Wheat Ridge
SCL Health Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org

Connecticut

Hartford
Smilow Cancer Hospital Care Center at Saint Francis
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu
New Haven
Smilow Cancer Center / Yale-New Haven Hospital
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu
Yale University
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu
North Haven
Yale-New Haven Hospital North Haven Medical Center
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu

Florida

Gainesville
University of Florida Health Science Center - Gainesville
Status: Active
Contact: Site Public Contact
Email: protocols@swog.org
Jacksonville
Baptist MD Anderson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 904-202-7051

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 404-778-1868
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: Active
Contact: Site Public Contact
Email: protocols@swog.org

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Site Public Contact
Email: protocols@swog.org
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: Active
Contact: Site Public Contact
Email: protocols@swog.org
Meridian
Saint Luke's Mountain States Tumor Institute - Meridian
Status: Active
Contact: Site Public Contact
Email: protocols@swog.org
Nampa
Saint Luke's Mountain States Tumor Institute - Nampa
Status: Active
Contact: Site Public Contact
Email: protocols@swog.org
Post Falls
Kootenai Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: Active
Contact: Site Public Contact
Email: protocols@swog.org

Illinois

Bloomington
Illinois CancerCare-Bloomington
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Canton
Illinois CancerCare-Canton
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Carthage
Illinois CancerCare-Carthage
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
Danville
Carle on Vermilion
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Decatur Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Effingham
Carle Physician Group-Effingham
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Crossroads Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Eureka
Illinois CancerCare-Eureka
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Galesburg
Illinois CancerCare-Galesburg
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Geneva
Northwestern Medicine Cancer Center Delnor
Status: Active
Contact: Site Public Contact
Phone: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Macomb
Illinois CancerCare-Macomb
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Maywood
Loyola University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 708-226-4357
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Pekin
Illinois CancerCare-Pekin
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Princeton
Illinois CancerCare-Princeton
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Rockford
SwedishAmerican Regional Cancer Center / ACT
Status: Active
Contact: Site Public Contact
Phone: 779-696-9400
Email: cancercare@swedishamerican.org
Springfield
Memorial Medical Center
Status: Active
Contact: Site Public Contact
Phone: 217-788-3528
Southern Illinois University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: Active
Contact: Site Public Contact
Phone: 800-444-7541
Swansea
Cancer Care Specialists of Illinois-Swansea
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Urbana
Carle Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
The Carle Foundation Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: Active
Contact: Site Public Contact
Phone: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org

Indiana

Richmond
Reid Health
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu

Iowa

Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Mercy Cancer Center-West Lakes
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Des Moines
Broadlawns Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Lutheran Hospital
Status: Active
Contact: Site Public Contact
Phone: 515-241-8704
Iowa Methodist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: Active
Contact: Site Public Contact
Phone: 515-282-2921
Medical Oncology and Hematology Associates-Laurel
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Mercy Medical Center - Des Moines
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Fort Dodge
Trinity Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-574-8302
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-237-1225
West Des Moines
Mercy Medical Center-West Lakes
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Methodist West Hospital
Status: Active
Contact: Site Public Contact
Phone: 515-343-1000

Kansas

Great Bend
Central Care Cancer Center - Great Bend
Status: Active
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Lawrence
Lawrence Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Wichita
Wesley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org

Kentucky

Bardstown
Flaget Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Louisville
Jewish Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Jewish Hospital Medical Center Northeast
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Saints Mary and Elizabeth Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

Louisiana

Baton Rouge
Baton Rouge General Medical Center
Status: Active
Contact: Site Public Contact
Phone: 225-381-6451
Hematology / Oncology Clinic LLP
Status: Active
Contact: Site Public Contact
Phone: 225-767-0822
New Orleans
Ochsner Medical Center Jefferson
Status: Active
Contact: Site Public Contact
Phone: 504-703-8712
Email: Gregory.Johnstone@ochsner.org
Tulane University Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 504-988-6121

Massachusetts

Burlington
Lahey Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 781-744-8027

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-865-1125
Battle Creek
Bronson Battle Creek
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Brighton
IHA Hematology Oncology Consultants-Brighton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Brighton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Brownstown
Henry Ford Cancer Institute¿Downriver
Status: Active
Contact: Site Public Contact
Email: protocols@swog.org
Canton
IHA Hematology Oncology Consultants-Canton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Canton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Chelsea
IHA Hematology Oncology Consultants-Chelsea
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Chelsea
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: Active
Contact: Site Public Contact
Phone: 313-916-1784
Dearborn
Beaumont Hospital-Dearborn
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 248-551-7695
Henry Ford Medical Center-Fairlane
Status: Active
Contact: Site Public Contact
Phone: 888-734-5322
Detroit
Ascension Saint John Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Henry Ford Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-1784
East China
Great Lakes Cancer Management Specialists-Doctors Park
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Flint
Genesys Hurley Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Gorsse Pointe Woods
Lymphoma Clinic of Michigan
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Grand Rapids
Mercy Health Saint Mary's
Status: Active
Contact: Site Public Contact
Email: protocols@swog.org
Spectrum Health at Butterworth Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Grosse Pointe Woods
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Michigan Breast Specialists-Grosse Pointe Woods
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Jackson
Allegiance Health
Status: Active
Contact: Site Public Contact
Phone: 517-788-4800
Kalamazoo
West Michigan Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Livonia
Saint Mary Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Michigan Breast Specialists-Macomb Township
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Muskegon
Mercy Health Mercy Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Novi
Henry Ford Medical Center-Columbus
Status: Active
Contact: Site Public Contact
Phone: 888-734-5322
Pontiac
Saint Joseph Mercy Oakland
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Reed City
Spectrum Health Reed City Hospital
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Rochester Hills
Great Lakes Cancer Management Specialists-Rochester Hills
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saginaw
Saint Mary's of Michigan
Status: Active
Contact: Site Public Contact
Email: protocols@swog.org
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Marie Yeager Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Traverse City
Munson Medical Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Warren
Advanced Breast Care Center PLLC
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Bhadresh Nayak MD PC-Warren
Status: Active
Contact: Christopher M. Reynolds
Phone: 734-712-3671
Great Lakes Cancer Management Specialists-Macomb Professional Building
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Macomb Hematology Oncology PC
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Michigan Breast Specialists-Warren
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint John Macomb-Oakland Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: Active
Contact: Site Public Contact
Phone: 888-734-5322
Ypsilanti
IHA Hematology Oncology Consultants-Ann Arbor
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org

Minnesota

Bemidji
Sanford Clinic North-Bemidgi
Status: Active
Contact: Site Public Contact
Phone: 218-333-5000
Burnsville
Fairview Ridges Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Coon Rapids
Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Duluth
Essentia Health Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org
Edina
Fairview-Southdale Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Fergus Falls
Lake Region Healthcare Corporation-Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org
Fridley
Unity Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint John's Hospital - Healtheast
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Minneapolis
Abbott-Northwestern Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Health Partners Inc
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Hennepin County Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Robbinsdale
North Memorial Medical Health Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Rochester
Mayo Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Paul
Regions Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
United Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Shakopee
Saint Francis Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Stillwater
Lakeview Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Waconia
Ridgeview Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Willmar
Rice Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Missouri

Bolivar
Central Care Cancer Center - Bolivar
Status: Active
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Bonne Terre
Parkland Health Center-Bonne Terre
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Cape Girardeau
Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 573-651-5550
Jefferson City
Capital Region Southwest Campus
Status: Active
Contact: Site Public Contact
Phone: 573-632-4814
Email: swooden@mail.crmc.org
Kansas City
Kansas City Veterans Affairs Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-525-1483
Rolla
Delbert Day Cancer Institute at PCRMC
Status: Active
Contact: Site Public Contact
Phone: 573-458-7504
Email: jrichards@research.pcrmc.com
Mercy Clinic-Rolla-Cancer and Hematology
Status: Active
Contact: Site Public Contact
Phone: 573-458-7504
Email: jrichards@research.pcrmc.com
Saint Louis
Mercy Hospital Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 314-251-6770
Missouri Baptist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Saint Louis Cancer and Breast Institute-South City
Status: Active
Contact: Site Public Contact
Phone: 314-353-1870
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Springfield
CoxHealth South Hospital
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520
Sullivan
Missouri Baptist Sullivan Hospital
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569

Montana

Billings
Billings Clinic Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Bozeman
Bozeman Deaconess Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Butte
Saint James Community Hospital and Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 406-723-2621
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Kalispell
Kalispell Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Missoula
Community Medical Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Saint Patrick Hospital - Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-327-3118
Email: amy.hanneman@providence.org

Nebraska

Grand Island
CHI Health Saint Francis
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Kearney
CHI Health Good Samaritan
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Omaha
University of Nebraska Medical Center
Status: Active
Contact: Site Public Contact
Phone: 402-559-6941
Email: unmcrsa@unmc.edu

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org

New York

Lake Success
Northwell Health / Center for Advanced Medicine
Status: Active
Contact: Site Public Contact
Phone: 516-734-8896
Manhasset
North Shore University Hospital
Status: Active
Contact: Site Public Contact
Phone: 516-734-8896
New Hyde Park
Long Island Jewish Medical Center
Status: Active
Contact: Site Public Contact
Phone: 516-734-8896
New York
Weill Medical College of Cornell University
Status: Active
Contact: Site Public Contact
Phone: 212-746-1848
Rochester
University of Rochester
Status: Active
Contact: Site Public Contact
Phone: 585-275-5830

North Carolina

Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Clinton
Southeastern Medical Oncology Center-Clinton
Status: Active
Contact: Site Public Contact
Phone: 919-587-9077
Email: ecooke@cancersmoc.com
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: Active
Contact: Site Public Contact
Phone: 919-587-9077
Email: ecooke@cancersmoc.com
Wayne Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 919-731-6687
Email: ecooke@cancersmoc.com
Hendersonville
Margaret R Pardee Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 828-696-4716
Email: karen.morris@unchealth.unc.edu
Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Status: Active
Contact: Site Public Contact
Phone: 910-353-0824
Email: ecooke@cancersmoc.com
Wilson
Southeastern Medical Oncology Center-Wilson
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-849-0203

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: tamara.fischer@sanfordhealth.org
Fargo
Roger Maris Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 701-234-6161
Sanford Broadway Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-437-4010

Ohio

Cincinnati
Good Samaritan Hospital - Cincinnati
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
TriHealth Cancer Institute-Anderson
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
TriHealth Cancer Institute-Westside
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Cleveland
MetroHealth Medical Center
Status: Active
Contact: Site Public Contact
Phone: 216-778-8526
Email: dstrater@metrohealth.org
Columbus
Columbus Oncology and Hematology Associates Inc
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Mount Carmel East Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Mount Carmel Health Center West
Status: Active
Contact: Site Public Contact
Phone: 614-234-5433
Email: sheree@columbusccop.org
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Riverside Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
The Mark H Zangmeister Center
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Dayton
Good Samaritan Hospital - Dayton
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Miami Valley Hospital
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Samaritan North Health Center
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Findlay
Blanchard Valley Hospital
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Marietta
Marietta Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-523-3977
Email: sheree@columbusccop.org
Newark
Licking Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 740-348-4000
Email: sheree@columbusccop.org
Springfield
Springfield Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Springfield Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Toledo
Toledo Clinic Cancer Centers-Toledo
Status: Active
Contact: Site Public Contact
Phone: 800-444-3561
Westerville
Saint Ann's Hospital
Status: Active
Contact: Site Public Contact
Email: protocols@swog.org

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Oregon

Clackamas
Clackamas Radiation Oncology Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Oncology and Hematology Care Southeast
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Coos Bay
Bay Area Hospital
Status: Active
Contact: Site Public Contact
Phone: 541-269-8392
Email: cherie.cox@bayareahospital.org
Newberg
Providence Newberg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Portland
Providence Portland Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Bryn Mawr
Bryn Mawr Hospital
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Paoli
Paoli Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
West Reading
Reading Hospital
Status: Active
Contact: Site Public Contact
Phone: 610-988-9323
Wynnewood
Lankenau Medical Center
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Contact: Site Public Contact
Phone: 843-792-9321
Email: hcc-clinical-trials@musc.edu
Greenwood
Self Regional Healthcare
Status: Active
Contact: Site Public Contact
Phone: 864-725-4771
Email: nmcgaha@selfregional.org

South Dakota

Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu

Washington

Edmonds
Swedish Medical Center-Edmonds
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Longview
PeaceHealth Saint John Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-514-2016
Email: kmakin-bond@peacehealth.org
Puyallup
MultiCare Good Samaritan Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-351-7955
Email: research@multicare.org
Seattle
Fred Hutchinson Cancer Research Center
Status: Active
Contact: Site Public Contact
Phone: 800-804-8824
Seattle Cancer Care Alliance
Status: Active
Contact: Site Public Contact
Phone: 800-804-8824
Swedish Medical Center-Ballard Campus
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-First Hill
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Vancouver
PeaceHealth Southwest Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-514-3940
Email: kmakin-bond@peacehealth.org

West Virginia

Charleston
West Virginia University Charleston Division
Status: Active
Contact: Site Public Contact
Phone: 304-388-9944

Wisconsin

Chippewa Falls
Marshfield Clinic-Chippewa Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
La Crosse
Gundersen Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 608-775-2385
Email: cancerctr@gundersenhealth.org
Ladysmith
Marshfield Clinic - Ladysmith Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
Marshfield
Marshfield Clinic
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Milwaukee
Froedtert and the Medical College of Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 414-805-4380
Minocqua
Marshfield Clinic-Minocqua Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
New Richmond
Cancer Center of Western Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Rice Lake
Marshfield Clinic-Rice Lake Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Wausau
Marshfield Clinic-Wausau Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Weston
Marshfield Clinic - Weston Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To compare the complete response rate at 6 cycles after randomization as defined by centrally read positron emission tomography (PET)/computed tomography (CT) (integral biomarker) of 2 targeted therapeutic regimens (obinutuzumab + umbralisib [TGR-1202] or obinutuzumab + lenalidomide) with obinutuzumab + chemotherapy (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone [CHOP] or bendamustine) in patients with early relapsing or refractory follicular lymphoma.

SECONDARY OBJECTIVES:

I. To validate the prognostic association of the m7-FLIPI model, demonstrating that the population of follicular lymphoma patients who respond poorly to chemoimmunotherapy are enriched for having a high-risk m7-FLIPI score, and that the score is associated with progression-free survival (integrated biomarker). (Primary translational medicine)

II. To estimate the 30-month sustained complete response rate (CR30) defined by centrally read PET/CT with each of the regimens in this early relapsing or refractory follicular lymphoma population.

III. To estimate best response at 12 cycles of therapy, progression free survival, duration of response and overall survival with each of the combinations in early relapsing or refractory follicular lymphoma.

IV. To evaluate the adverse effects of each of the regimens in early relapsing or refractory follicular lymphoma.

V. To evaluate the predictive performance of non-invasive genotyping (m7-FLIPI in circulating tumor deoxyribonucleic acid [DNA]) of plasma at study entry relative to standard tumor genotyping (m7-FLIPI) of formalin-fixed paraffin-embedded tumor tissue.

VI. To evaluate the association between the detection of active lymphoma by PET-CT and the detection of circulating tumor DNA in plasma at baseline, after 6 and 12 cycles, and at 30 months after initiation of study therapy.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive obinutuzumab intravenously (IV) on day 1 and umbralisib orally (PO) daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive obinutuzumab IV on day 1 and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up 12 courses in the absence of disease progression or unacceptable toxicity.

ARM III:

PRIOR BENDAMUSTINE-BASED CHEMOTHERAPY: Patients receive obinutuzumab IV on day 1, cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment with obinutuzumab repeats every 21 or 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Treatment with combination chemotherapy repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

PRIOR CHOP CHEMOTHERAPY: Patients receive obinutuzumab IV on day 1, and bendamustine IV over 60 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 or 12 courses (bendamustine and obinutuzumab, respectively) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
SWOG

Principal Investigator
Paul Michael Barr

Trial IDs

Primary ID S1608
Secondary IDs NCI-2017-00009
Clinicaltrials.gov ID NCT03269669