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Clinical Trials (PDQ®)

Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overNCINCI-2013-00959
ECOG-E1412, E1412, U10CA021115, U10CA180820, NCT01856192

Trial Description

Summary

This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide works in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.

Further Study Information

PRIMARY OBJECTIVES:

I. Progression-free survival (PFS).

SECONDARY OBJECTIVES:

I. Response rate (RR). II. Complete remission (CR) rate as defined by positron emission tomography (PET)-computed tomography (CT) criteria.

III. Overall survival (OS).

TERTIARY OBJECTIVES:

I. Impact of diffuse large B cell lymphoma (DLBCL) molecular subtype on outcome.

II. Interim PET scan results in relation to treatment outcome.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive rituximab intravenously (IV), cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1; prednisone orally (PO) on days 1-5; and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone as in Arm A. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patient are followed up every 3 months for 2 years, every 6 months for 1 year, and then annually for up to 7 years.

Eligibility Criteria

Inclusion Criteria:

  • Histologically confirmed DLBCL expressing cluster of differentiation (CD)20 antigen; patients with transform lymphoma are excluded; patients with known primary mediastinal large B-cell lymphoma (PMLBCL) are excluded; similarly, patients with known v-myc myelocytomatosis viral oncogene homolog (avian) (c-myc) translocation (by fluorescence in situ hybridization) positive DLBCL are encouraged to participate in trials specifically designed for these patients; however patients with known c-myc positive are NOT excluded from this study; c-myc testing prior to study enrollment is NOT required
  • Stages II bulky disease (defined as mass size of more than 10 cm), stage III, or IV (Ann Arbor staging); patients with stage I and stage II non-bulky disease are excluded from this study
  • A tumor tissue specimen from the initial diagnostic biopsy has been located and ready to ship to the Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) Pathology Coordinating Office within 30 days following registration; patients must have paraffin-embedded tumor specimen available for central pathology review and defined laboratory research studies; archived formalin fixed paraffin embedded (FFPE) tumor tissue block is required; if the block is unavailable for submission, please submit the below alternative requirements:
  • One (1) hematoxylin & eosin (H&E) slide, and
  • Twenty (20) 4 um unstained air-dried plus slides, and
  • One (1) or more core punches (minimum of 4 mm diameter)
  • International Prognostic Index (IPI) of 2 or greater
  • ECOG performance status 0-2
  • Patients must have measurable disease (at least 1 lesion of >= 1.5 cm in one diameter) as detected by CT or the CT images of the PET/CT
  • Previously untreated and not receiving any other agent that would be considered as a treatment for the lymphoma
  • No known central nervous system (CNS) lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells; these patients are usually treated with CNS directed therapy; screening for cerebrospinal fluid (CSF)/CNS involvement is NOT required but can be performed per treating medical doctor (MD) discretion
  • Absolute neutrophil count (ANC) >= 1500
  • Platelets (PLT) >= 100,000
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be normal
  • Alkaline (Alk.) phosphatase =< 3 x ULN unless evidence of the direct liver involvement by lymphoma--then =< 5 x ULN
  • Aspartate aminotransferase (AST) =< 3 x ULN unless evidence of the direct liver involvement by lymphoma-then =< 5 x ULN
  • Creatinine =< 2 x ULN or creatinine clearance (CrCl) > 30 ml/min
  • Ejection fraction of >= 45% by either multi gated acquisition scan (MUGA) or echocardiogram (ECHO)
  • Absence of co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Absence of history of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • Absence of history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia; patients with history of deep vein thrombosis/embolism/thrombophilia may participate if they are on full anticoagulation during the treatment (warfarin or low molecular weight heparin at therapeutic doses)
  • Patient must be able and willing to receive anticoagulation therapy with aspirin 325 mg daily prophylaxis, low molecular weight heparin, or warfarin; patients unable or unwilling to take any prophylaxis are NOT eligible
  • Absence of history of acquired immune deficiency syndrome (AIDS)-related conditions (other than the presenting DLBCL) or post-transplant lymphoproliferative disorder (PTLD) in immunocompromised patients; patients with human immunodeficiency virus (HIV) on antiretroviral therapy other than zidovudine (AZT) and/or stavudine and without prior AIDS defining conditions and adequate CD4 count (> 400) are eligible
  • No other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy; exceptions to this are as follows: localized non-melanotic skin cancer and any cancer that in the judgment of the investigator has been treated with curative intent and will not interfere with the study treatment plan and response assessment
  • No history of radiation therapy to >= 25% of the bone marrow for other diseases or history of anthracycline therapy
  • Patients must not be receiving erythroid stimulating agents (erythropoietin [EPO]: Procrit, Aranesp)
  • Patient must be willing to provide informed written consent and to return to enrolling institution for follow-up
  • Women must not be pregnant or breast-feeding
  • 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 prior to and again within 24 hours of starting 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; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) 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)
  • 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

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Grzegorz NowakowskiPrincipal Investigator

Trial Sites

U.S.A.
Arizona
  Scottsdale
 Mayo Clinic Scottsdale
 Grzegorz S Nowakowski Ph: 507-538-7623
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Aurora
 Keren Sturtz Ph: 888-785-6789
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers at the Pavilion
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
 Colorado Blood Cancer Institute
 Keren Sturtz Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Denver Midtown
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Rose
 Keren Sturtz Ph: 888-785-6789
 Rose Medical Center
 Keren Sturtz Ph: 888-785-6789
 St. Joseph Hospital
 Keren Sturtz Ph: 888-785-6789
  Durango
 Mercy Medical Center
 Keren Sturtz Ph: 888-785-6789
  Englewood
 Comprehensive Cancer Care and Research Institute of Colorado LLC
 Keren Sturtz Ph: 888-785-6789
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Golden
 Mountain Blue Cancer Care Center
 Keren Sturtz Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greenwood Village
 Breast Cancer Care Consultants
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 Rocky Mountain Cancer Centers-Lakewood
 Keren Sturtz Ph: 888-785-6789
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Littleton
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Rocky Mountain Cancer Centers - Lone Tree
 Keren Sturtz Ph: 888-785-6789
 Sky Ridge Medical Center
 Keren Sturtz Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Keren Sturtz Ph: 888-785-6789
  Parker
 Parker Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Parker
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 St. Mary - Corwin Regional Medical Center
 Keren Sturtz Ph: 888-785-6789
  Thornton
 Rocky Mountain Cancer Centers - Thornton
 Keren Sturtz Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-4673
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
Illinois
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Adam M Petrich Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Elk Grove Village
 Cancer Institute at Alexian Brothers
 Bruce B. Bank Ph: 847-952-7164
  Email: fredianc@alexian.net
  Galesburg
 Medical and Surgical Specialists, LLC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Hinsdale
 Hinsdale Hematology Oncology Associates
 Elyse Cheryl Schneiderman Ph: 630-654-1790
  Email: info@hhoaltd.com
  Niles
 Cancer Care and Hematology Specialists of Chicagoland - Niles
 Adam M Petrich Ph: 312-695-1301
  Email: cancer@northwestern.edu
Indiana
  Elkhart
 Elkhart Clinic, LLC
 Jose A. Bufill Ph: 574-237-1328
 Michiana Hematology-Oncology, PC - Elkhart
 Jose A. Bufill Ph: 574-237-1328
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 Jose A. Bufill Ph: 574-237-1328
 Saint Joseph's Medical Center
 Jose A. Bufill Ph: 574-237-1328
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Jose A. Bufill Ph: 574-237-1328
  Richmond
 Reid Hospital & Health Care Services
 Howard M. Gross Ph: 937-775-1350
  South Bend
 CCOP - Northern Indiana CR Consortium
 Jose A. Bufill Ph: 574-237-1328
 Michiana Hematology-Oncology, PC - South Bend
 Jose A. Bufill Ph: 574-237-1328
  Westville
 Michiana Hematology Oncology-PC Westville
 Jose A. Bufill Ph: 574-237-1328
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Mason City
 Mercy Cancer Center at Mercy Medical Center - North Iowa
 Arvind Y Vemula Ph: 800-433-3883
  Sioux City
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
Louisiana
  Baton Rouge
 Ochsner Health Center - Bluebonnet
 Robert V. Emmons Ph: 888-562-4763
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Robert V. Emmons Ph: 888-562-4763
Michigan
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Christopher M Reynolds Ph: 734-712-4673
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Christopher M Reynolds Ph: 734-712-4673
  Pontiac
 St. Joseph Mercy Oakland
 Christopher M Reynolds Ph: 734-712-4673
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Christopher M Reynolds Ph: 734-712-4673
  Warren
 St. John Macomb Hospital
 Christopher M Reynolds Ph: 734-712-4673
Minnesota
  Rochester
 Mayo Clinic Cancer Center
 Grzegorz S Nowakowski Ph: 507-538-7623
Missouri
  Bolivar
 Central Care Cancer Center at Carrie J. Babb Cancer Center
 Jay W Carlson Ph: 800-821-7532
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
New Jersey
  Livingston
 St. Barnabas Medical Center Cancer Center
 Miguel A. Conde Ph: 973-322-2470
  Vineland
 Frank and Edith Scarpa Regional Cancer Pavillion at South Jersey Healthcare
 Ramakrishna Sudhindra Ph: 856-641-7933
New York
  Buffalo
 Roswell Park Cancer Institute
 Francisco J Hernandez-ILizaliturri Ph: 877-275-7724
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Jonathan W Friedberg Ph: 585-275-5830
  Syracuse
 SUNY Upstate Medical University Hospital
 Teresa C. Gentile Ph: 315-464-5476
Ohio
  Dayton
 David L. Rike Cancer Center at Miami Valley Hospital
 Howard M. Gross Ph: 937-775-1350
 Good Samaritan Hospital
 Howard M. Gross Ph: 937-775-1350
 Samaritan North Cancer Care Center
 Howard M. Gross Ph: 937-775-1350
Pennsylvania
  Bryn Mawr
 Bryn Mawr Hospital
 Albert S DeNittis Ph: 866-225-5654
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Edward J Gorak Ph: 570-271-5251
  Ephrata
 Ephrata Cancer Center at Ephrata Community Hospital
 Amir Tabatabai Ph: 877-441-7957
 Amir Tabatabai Ph: 877-441-7957
  Gettysburg
 Adams Cancer Center
 Amir Tabatabai Ph: 877-441-7957
  Hanover
 Cherry Tree Cancer Center
 Amir Tabatabai Ph: 877-441-7957
  Hazleton
 Geisinger Hazleton Cancer Center
 Edward J Gorak Ph: 570-271-5251
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Albert S DeNittis Ph: 866-225-5654
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Nadia Khan Ph: 215-728-4790
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Barbara Pro Ph: 215-955-6084
 Temple Cancer Center at Temple University Hospital
 Nadia Khan Ph: 215-728-4790
  Pottstown
 Pottstown Memorial Regional Cancer Center
 Wei Song Ph: 610-327-7544
  Scranton
 Hematology and Oncology Associates of North East Pennsylvania
 Barbara Pro Ph: 215-955-6084
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Terrence P. Cescon Ph: 610-988-9323
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Edward J Gorak Ph: 570-271-5251
  Wynnewood
 Lankenau Cancer Center at Lankenau Hospital
 Albert S DeNittis Ph: 866-225-5654
  York
 WellSpan Health
 Amir Tabatabai Ph: 877-441-7957
Tennessee
  Nashville
 Vanderbilt-Ingram Cancer Center
 Nishitha Reddy Ph: 800-811-8480
Texas
  Austin
 University Medical Center Brackenridge
 Alka Mallik Ph: 512-324-7991
Virginia
  Charlottesville
 University of Virginia Cancer Center
 Michael Eugene Williams Ph: 434-243-6143
Wisconsin
  Antigo
 Langlade Memorial Hospital
 Hamied R. Rezazadeh Ph: 877-405-6866
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Timothy S Fenske Ph: 414-805-4380
 Oncology Alliance, SC - Milwaukee - South
 Rubina Qamar Ph: 888-709-2080
  Wausau
 University of Wisconcin Cancer Center at Aspirus Wausau Hospital
 Hamied R. Rezazadeh Ph: 877-405-6866

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01856192
ClinicalTrials.gov processed this data on November 25, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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