Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Patients with Previously Untreated Mantle Cell Lymphoma

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIBiomarker/Laboratory analysis, Supportive care, TreatmentActive60 and overE1411
NCI-2011-02980, CDR0000707057, ECOG-E1411, NCT01415752

Trial Description

Summary

This randomized phase II trial studies how well rituximab, bendamustine hydrochloride, and bortezomib followed by rituximab and lenalidomide works in treating patients with previously untreated mantle cell lymphoma. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab with bendamustine hydrochloride and bortezomib is more effective than rituximab and bendamustine hydrochloride, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine whether the addition of bortezomib (RBV) to an induction regimen of rituximab-bendamustine (bendamustine hydrochloride) (RB) improves progression-free survival (PFS) compared to RB alone in patients with previously untreated mantle cell lymphoma.

II. To determine whether the addition of lenalidomide to a consolidation regimen of rituximab following an induction regimen of RB or RBV improves PFS compared to consolidation rituximab alone in this patient population.

SECONDARY OBJECTIVES:

I. To determine whether the addition of bortezomib to induction therapy improves the positron emission tomography (PET)-documented complete response rate compared to RB alone.

II. To determine the objective response rate (ORR) for RB and RBV.

III. Among patients who do not have PET-documented complete response (CR) at the end of induction, to determine whether the addition of lenalidomide to consolidation therapy improves CR and ORR compared with rituximab alone.

IV. To determine overall survival (OS) in the treatment arms.

V. To determine safety, with attention to the addition of bortezomib in the induction regimen and lenalidomide-rituximab as consolidation therapy.

TERTIARY OBJECTIVES:

I. To collect paraffin embedded tissue for creation of tissue microarray.

II. To collect and bank serum and blood mononuclear cells for future studies.

III. To collect formalin-fixed paraffin-embedded (FFPE) tissue to analyze potential prognostic factors: Ki-67 antigen (Ki-67) proliferation index by immunohistochemistry and correlation with proposed 5-gene set of proliferation markers analyzed by ribonucleic acid (RNA) polymerase chain reaction (PCR); SRY (sex determining region Y)-box 11 (SOX 11) expression by immunohistochemistry; and micro-RNA levels by microarray.

IV. Using patient-reported outcomes data, to determine the extent and severity of neuropathy associated with the addition of bortezomib to induction treatment.

V. Using patient-reported outcomes data, to determine the extent and severity of fatigue associated with the addition of lenalidomide to consolidation treatment.

VI. To evaluate the effects of the addition of bortezomib and lenalidomide on patient-reported health-related quality of life.

VII. To evaluate the effects of bortezomib-related neuropathy on patient-reported health-related quality of life.

VIII. To evaluate the response of lymphoma-specific symptoms to treatment.

IX. Using longitudinal patient-reported outcomes data, to describe the trajectory of lymphoma symptoms, neuropathy, fatigue, and overall health-related quality of life prior to, during, and following treatment among older adults with mantle cell lymphoma (MCL).

X. To assess the proportion of patients up and down staging when fludeoxyglucose F 18- (FDG) PET/computed tomography (CT) is added to standard Ann Arbor staging.

XI. To assess the ability of pre-treatment FDG-PET/CT semi quantitative parameters including maximum standardized uptake value (SUVmax) and metabolic measurements to predict response rate and PFS.

XII. Among patients with interim FDG-PET/CT imaging, to assess the correlation of interim FDG-PET/CT imaging with response rate and PFS both during induction and consolidation therapy.

XIII. To assess standard FDG-PET/CT metrics including SUVmax, tumor metabolic burden, total tumor burden, and association with pathology features (blastoid variant vs. other, and Ki67) in the setting of MCL.

XIV. To assess differences in overall and complete response rates when using Deauville vs International Harmonization Project FDG-PET/CT interpretation criteria.

XV. To determine whether there is a correlation between FDG-PET/CT response and residual disease assessment by molecular and/or flow cytometric techniques.

XVI. To determine whether the number of malignant cells in circulation predict the number of cells in marrow.

XVII. To determine whether the number of malignant cells in circulation/in marrow at the end of induction correlate with CR and 2-year PFS.

XVIII. To determine whether there is a higher rate of minimal residual disease (MRD) negativity among patients randomized to RBV as compared with RB, and among patients treated with lenalidomide-rituximab (LR) maintenance compared with rituximab (R).

XIX. To compare the two methods of MRD detection - molecular techniques and flow cytometry as prognostic markers for outcome.

OUTLINE:

STEP 1: Patients are randomized to 1 of 4 treatment arms.

ARM A: Patients receive induction therapy comprising rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive induction therapy comprising bortezomib subcutaneously (SC) or IV on days 1 and 8, and rituximab and bendamustine hydrochloride as in Arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM C: Patients receive induction therapy comprising rituximab and bendamustine hydrochloride as patients in Arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM D: Patients receive bortezomib, rituximab, and bendamustine hydrochloride as in arm B. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

STEP 2: Patients with improved response or no interval change in their tumor measurements with restaging from courses 3 to 6 in Step 1 are assigned to 1 of 4 arms.

ARM E (after Arm A): Patients receive consolidation therapy comprising rituximab IV on day 1. Treatment repeats every 8 weeks for 12 doses in the absence of disease progression or unacceptable toxicity.

ARM F (after Arm B): Patients receive consolidation therapy comprising rituximab IV on day 1 as in Arm E. Treatment repeats every 8 weeks for 12 doses in the absence of disease progression or unacceptable toxicity.

ARM G (after Arm C): Patients receive consolidation therapy comprising lenalidomide orally (PO) daily on days 1-21 every 28 days for 24 courses and rituximab IV every 8 weeks for 12 doses in the absence of disease progression or unacceptable toxicity.

ARM H (after Arm D): Patients receive consolidation therapy comprising lenalidomide PO daily on days 1-21 every 28 days for 24 courses and rituximab IV every 8 weeks for 12 doses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2.5 years, every 6 months for 8 years, and then annually for 5 years.

Eligibility Criteria

Inclusion Criteria:

STEP 1 REGISTRATION:

Mantle cell lymphoma International Prognostic Index (IPI) (MIPI) score must be calculated and entered in Oncology Patient Enrollment Network (OPEN)

NOTE: for this calculation white blood cell (WBC) 7,500/mm^3 = 7,500/uL = 7.5 x 10^9/L should be entered as 7500

Females of childbearing potential must not be pregnant or breast feeding;

All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy

A female of childbearing potential (FCBP) is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception

Patients must have measurable disease

Histologically confirmed untreated mantle cell lymphoma, with documented cyclin D1 (BCL1) by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescent in situ hybridization (FISH)

Patients must have at least one objective measurable disease parameter; baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging; measurable disease in the liver is required if the liver is the only site of lymphoma; if the only radiographically assessable disease is splenomegaly (without discrete measurable nodules), the patient can be enrolled, but for such patients CR cannot be differentiated from PR, while the spleen will be considered nodal with respect to criteria for progressive disease (PD)

Eastern Cooperative Oncology Group (ECOG) performance status between 0-2

Absolute neutrophil count (ANC) >= 1,500/mm^3 (1.5 x 10^9/L) (unless due to marrow involvement) obtained within 4 weeks prior to registration

Platelets >= 100,000/mm^3 (100 x 10^9/L) (unless due to marrow involvement) obtained within 4 weeks prior to registration

Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2 x upper limit of normal (ULN) obtained within 4 weeks prior to registration

Total bilirubin =< 2 x upper limit of normal (ULN) or, if total elevated, direct bilirubin =< 2 x upper limit of normal (ULN) obtained within 4 weeks prior to registration

Calculated creatinine clearance by Cockroft-Gault formula >= 30 mL/min obtained within 4 weeks prior to registration

No evidence of prior malignancy except: adequately treated non-melanoma skin cancer, adequately treated in situ carcinoma, low grade prostate carcinoma (Gleason grade =< 6) managed with observation that has been stable for at least 6 months, or any malignancy treated with curative intent continuously disease free for >= 3 years so as not to interfere with interpretation of radiographic response

No prior therapy for MCL, except: < 2 weeks of steroid therapy for symptom control or local radiation therapy for symptom control if there is measurable disease outside the radiation portal; patients may be on chronic steroids for non-malignant disease if on a stable dose equivalent to =< 20 mg prednisone per day

Patient must have no known central nervous system (CNS) involvement

Patient agrees that if randomized to Arms C or D, and proceeding onto Arms G or H, they must register into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist

Patients must have no medical contra-indications to, and be willing to take, deep vein thrombosis (DVT) prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have deep vein thrombosis (DVT) prophylaxis; patients randomized to Arms G or H who have a history of a thrombotic vascular event will be required to have full anticoagulation, therapeutic doses of low-molecular weight heparin or warfarin to maintain an international normalized ratio (INR) between 2.0-3.0, or any other accepted full anticoagulation regimen (e.g., direct thrombin inhibitors or factor Xa inhibitors) with appropriate monitoring for that agent; patients on Arms G and H without a history of a thromboembolic event are required to take a daily aspirin (81 mg or 325 mg) for DVT prophylaxis; patients who are unable to tolerate aspirin should receive low molecular weight heparin therapy or warfarin treatment or another accepted full anticoagulation regimen

Ways to minimize risk of DVT should be discussed with patients, including, but not limited to, avoiding smoking, minimizing pro-thrombotic hormone replacement, avoiding prolonged periods of inactivity (e.g. uninterrupted long car or plane trips)

Human immunodeficiency virus (HIV)-positive patients are not excluded but, to enroll, must meet all of the below criteria:

HIV is sensitive to antiretroviral therapy

Must be willing to take effective antiretroviral therapy, if indicated

Cluster of differentiation (CD)4 count at screening >= 300 cells/mm^3

No history of acquired immunodeficiency syndrome (AIDS)-defining conditions

If on antiretroviral therapy, must not be taking zidovudine or stavudine

Must be willing to take prophylaxis for pneumocystis jiroveci pneumonia (PCP) during therapy and until at least 2 months following the completion of therapy or until the CD4 cells recover to over 250 cells/mm^3, whichever occurs later

Patients must not have grade 2 or greater peripheral neuropathy

Patients must not have New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia

Patients must not have hypersensitivity to bortezomib, boron or mannitol

Patients must not have a serious medical or psychiatric illness likely to interfere with study participation

Patients must not be participating in any other therapeutic clinical trial or taking any other experimental medications within 14 days prior to registration

STEP 2 REGISTRATION:

ECOG performance status between 0-2

CR, partial response (PR) or stable disease (SD) after Step 1

ANC >= 1000 cells/mm^3 (1.0 x 10^9/L)

Platelets >= 75,000 cells/mm^3 (75 x 10^9/L)

AST/ALT =< 2 x upper limit of normal (ULN)

Total bilirubin =< 2 x upper limit of normal (ULN) or, if total elevated, direct bilirubin =< 2 x upper limit of normal (ULN)

Calculated creatinine clearance by Cockroft-Gault formula >= 30 ml/min

Patient agrees that if randomized to Arms C or D, and proceeding onto Arms G or H, they must register into the mandatory Risk Evaluation and Mitigation Strategies (REMS) program, and be willing and able to comply with the requirements of Rems

Pregnancy tests must occur within 10-14 days and again within 24 hours prior to initiation of cycle 1 of lenalidomide; females of childbearing potential (FCBP) with regular or no menstruation must have a pregnancy test weekly for the first 28 days and then every 28 days while on lenalidomide therapy (including breaks in therapy); at discontinuation of lenalidomide and at day 28 post the last dose of lenalidomide; females with irregular menstruation must have a pregnancy test weekly for the first 28 days and then every 14 days while on lenalidomide therapy (including breaks in therapy), at discontinuation of lenalidomide and at day 14 and day 28 post the last dose of lenalidomide

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 and must either commit to continued abstinence 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 she starts taking 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, all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure

A female of childbearing potential is any sexually mature female, regardless of sexual orientation of whether they have undergone tubal ligation, who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; or 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)

Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study/lenalidomide: for at least 28 days before starting lenalidomide; while participating in the study including interruptions in therapy; and for at least 28 days after discontinuation/stopping lenalidomide; the two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal (birth control pills, injections, or implants, tubal ligation, partner’s vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap); FCBP must be referred to a qualified provider of contraceptive methods if needed

Women must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from protocol treatment

Males must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from protocol treatment

All males, regardless of whether they have undergone a successful vasectomy, must agree to use a latex condom during sexual contact with a female of childbearing potential, or to practice complete abstinence from heterosexual intercourse with any female of childbearing potential during all cycles of study treatment and for at least 28 days following discontinuation of protocol treatment

Patients must have no medical contra-indications to, and be willing to take, DVT prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have deep vein thrombosis (DVT) prophylaxis; patients randomized to Arms G or H who have full anticoagulation, a history of a thrombotic vascular event will be required to have therapeutic doses of low molecular weight heparin or warfarin to maintain an INR between 2.0 – 3.0, or any other accepted full anticoagulation regimen (e.g., direct thrombin inhibitors or factor Xa inhibitors) with appropriate monitoring for that agent; patients on Arms G and H without a history of a thromboembolic event are required to take a daily aspirin (81 mg or 325 mg) for DVT prophylaxis; patients who are unable to tolerate aspirin should receive low molecular weight heparin therapy or warfarin treatment or another accepted full anticoagulation regimen

Ways to minimize risk of DVT should be discussed with patients, including, but not limited to, avoiding smoking, minimizing pro-thrombotic hormone replacement, avoiding prolonged periods of inactivity (e.g uninterrupted long car or plane trips)

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

ECOG-ACRIN Cancer Research Group

  • National Cancer Institute
Mitchell Reed Smith, Principal Investigator

Trial Sites

U.S.A.

Colorado
Denver

Colorado Cancer Research Program NCORP

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Illinois
Bloomington

Illinois CancerCare-Bloomington

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Saint Joseph Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Canton

Illinois CancerCare-Canton

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Carbondale

Memorial Hospital of Carbondale

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Carthage

Illinois CancerCare-Carthage

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Centralia

Centralia Oncology Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Decatur

Cancer Care Center of Decatur

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Decatur Memorial Hospital

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Effingham

Crossroads Cancer Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Eureka

Illinois CancerCare-Eureka

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Galesburg

Illinois CancerCare-Galesburg

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Western Illinois Cancer Treatment Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Kewanee

Illinois CancerCare-Kewanee Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Macomb

Illinois CancerCare-Macomb

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Ottawa

Illinois CancerCare-Ottawa Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Radiation Oncology of Northern Illinois

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Pekin

Illinois CancerCare-Pekin

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Peoria

Illinois CancerCare-Peoria

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Methodist Medical Center of Illinois

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

OSF Saint Francis Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Peru

Illinois CancerCare-Peru

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Valley Radiation Oncology

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Springfield

Central Illinois Hematology Oncology Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Memorial Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Southern Illinois University School of Medicine

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Springfield Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Swansea

Cancer Care Specialists of Illinois-Swansea

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Maryland
Silver Spring

Holy Cross Hospital

Frederick David Min
Ph: 310-754-7552

Frederick David Min
Principal Investigator

Missouri
Bonne Terre

Parkland Health Center-Bonne Terre

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Cape Girardeau

Saint Francis Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Southeast Cancer Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Jefferson City

Capital Region Medical Center-Goldschmidt Cancer Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Saint Louis

Missouri Baptist Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Sainte Genevieve

Sainte Genevieve County Memorial Hospital

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Sullivan

Missouri Baptist Sullivan Hospital

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Sunset Hills

Missouri Baptist Outpatient Center-Sunset Hills

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Montana
Billings

Montana Cancer Consortium NCORP

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

New York
Auburn

Hematology Oncology Associates of Central New York-Auburn

Jeffrey J. Kirshner
Ph: 315-472-7504
Email: JKIRSHNER@HOACNY.COM

Jeffrey J. Kirshner
Principal Investigator

East Syracuse

Hematology Oncology Associates of Central New York-East Syracuse

Jeffrey J. Kirshner
Ph: 315-472-7504
Email: JKIRSHNER@HOACNY.COM

Jeffrey J. Kirshner
Principal Investigator

Rochester

University of Rochester

Jonathan Willmann Friedberg
Ph: 585-275-5830
Email: jonathan_friedberg@urmc.rochester.edu

Jonathan Willmann Friedberg
Principal Investigator

Syracuse

Hematology Oncology Associates of Central New York-Onondaga Hill

Jeffrey J. Kirshner
Ph: 315-472-7504
Email: JKIRSHNER@HOACNY.COM

Jeffrey J. Kirshner
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01415752

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.