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Clinical Trials (PDQ®)

Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIDiagnostic, TreatmentActive18 and overNCI, OtherCDR0000433265
CALGB-50303, ECOG-50303, NCI-05-C-0252, NCT00118209

Trial Description

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating diffuse large B-cell non-Hodgkin's lymphoma. Imaging procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET)/computed tomography (CT), may help diagnose if recurrent disease is likely.

PURPOSE: This randomized phase III trial is studying rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell non-Hodgkin's lymphoma.

Further Study Information

OBJECTIVES:

Primary

  • Compare the event-free survival of patients with previously untreated de novo diffuse large B-cell non-Hodgkin's lymphoma treated with R-CHOP comprising rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone vs EPOCH-R comprising etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab.
  • Determine molecular predictors of outcome (using molecular profiling) in patients treated with these regimens.

Secondary

  • Compare the response rate and overall survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Correlate the clinical parameters (i.e., toxicity, response, survival outcomes, and laboratory results) with molecular profiling in patients treated with these regimens.
  • Assess the use of molecular profiling for pathological diagnosis in patients treated with these regimens.
  • Identify new therapeutic targets using molecular profiling.
  • Perform a comprehensive analysis of somatic alterations to the tumor genome in order to understand which genomic alterations are somatically acquired by the tumor and which are encoded in the germ line of the patient.
  • Identify biomarkers of response to chemotherapy by FDG-PET/CT imaging that are predictive of histopathologic remissions and survival in patients with stage I (mediastinal), II, III, or IV untreated DLBCL.
  • Evaluate the use of semiquantitative measurements of FDG uptake in defining FDG-PET/CT-based biomarkers of response to chemotherapy in patients with DLBCL.
  • Determine whether FDG-PET/CT measurements of tumor response after the second cycle of chemotherapy can predict clinical response.
  • Establish a standardized protocol for FDG-PET/CT image acquisition.
  • Determine additional FDG-PET/CT parameters (e.g., the ratio of tumor SUVmax to liver SUVmean; SUVs corrected for body surface area and lean body mass; nuclear medicine physician's assessment) and evaluate their utility in refining FDG-PET/CT based biomarkers of response to therapy.
  • Evaluate inter-institutional reproducibility of FDG-PET/CT measurements for this indication.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to International Prognostic Index score. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (R-CHOP): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin IV over 3-5 minutes, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II (EPOCH-R): Patients receive rituximab IV on day 1, doxorubicin IV, etoposide IV, and vincristine IV continuously over 96 hours on days 1-4, cyclophosphamide IV on day 5, and oral prednisone twice daily on days 1-5. Patients also receive filgrastim (G-CSF) once daily on days 2-11 or until blood counts recover. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

As of July 1, 2012, the FDG-PET/CT imaging companion study CALGB-580603 will be required of all patients enrolling on this study. FDG-PET/CT scans of abdomen/chest/pelvis are collected at baseline, post-course 2, and post-course 6.

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

PROJECTED ACCRUAL: A total of 478 patients (239 per treatment arm) will be accrued for this study within 4.5 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed* de novo B-cell non-Hodgkin's lymphoma (NHL) of 1 of the following WHO histologic subtypes:
  • Diffuse large cell lymphoma, including any of the following morphologic variants:
  • Centroblastic
  • Immunoblastic
  • T-cell/histiocyte rich
  • Anaplastic
  • Mediastinal (thymic) large cell lymphoma
  • Intravascular large cell lymphoma NOTE: *Fine needle aspirates or core biopsies must not be the only diagnostic material
  • Stage I primary mediastinal (thymic) OR stage II-IV disease
  • CD20-positive disease
  • No underlying low-grade lymphoma (e.g., transformed lymphoma or low-grade lymphoma in the bone marrow)
  • No known lymphomatous CNS involvement
  • Lumbar puncture required unless there are no neurological symptoms
  • As of July 1, 2012, the PET/CT imaging companion study CALGB-580603 will be required of all patients enrolling onto the treatment study CALGB-50303 NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3^*
  • Platelet count ≥ 100,000/mm^3^*
  • No active bleeding unrelated to NHL NOTE: *Unless due to NHL

Hepatic

  • Bilirubin ≤ 2 mg/dL* NOTE: *Unless due to NHL or Gilbert's disease

Renal

  • Creatinine ≤ 1.5 mg/dL^* OR
  • Creatinine clearance ≥ 50 mL/min^* NOTE: *Unless due to NHL

Cardiovascular

  • No active ischemic heart disease
  • No congestive heart failure

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No active uncontrolled bacterial or viral infection unrelated to NHL
  • No other active medical process unrelated to NHL

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior rituximab

Chemotherapy

  • No prior chemotherapy for other malignancies
  • No prior cytotoxic chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • Prior short course (< 10 days) glucocorticoids allowed for an urgent local disease complication (e.g., cord compression or superior vena cava syndrome) at diagnosis
  • No concurrent hormonal therapy except steroids for adrenal failure or hormones for non-disease related conditions (e.g., insulin for diabetes)
  • No concurrent dexamethasone or other steroidal antiemetics

Radiotherapy

  • Prior limited field radiotherapy allowed for an urgent local disease complication (e.g., cord compression or superior vena cava syndrome) at diagnosis
  • No concurrent radiotherapy except for isolated CNS lesions

Surgery

  • Not specified

Other

  • No other concurrent investigational or commercial agents or therapies for NHL

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

National Cancer Institute

Wyndham Hopkins WilsonStudy Chair

Andrew D. Zelenetz

Trial Sites

U.S.A.
California
  Northridge
 Northridge Hospital Medical Center
 Sheldon J. Davidson Ph: 818-885-5458
Georgia
  Albany
 Phoebe Cancer Center at Phoebe Putney Memorial Hospital
 Jose M. Tongol Ph: 229-312-2251
  Savannah
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 O. George Negrea Ph: 912-350-8568
Illinois
  Chicago
 Cancer and Leukemia Group B
 Wyndham Hopkins Wilson Ph: 301-435-2415
  Email: wilsonw@mail.nih.gov
 Louis A. Weiss Memorial Hospital
 Keith L. Shulman Ph: 773-564-5044
Louisiana
  Baton Rouge
 Ochsner Health Center - Bluebonnet
 Charles V Wendling Ph: 888-562-4763
  Covington
 Ochsner Health Center - Covington
 Charles V Wendling Ph: 888-562-4763
  New Orleans
 CCOP - Ochsner
 Charles V Wendling Ph: 888-562-4763
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Vincent E Herrin Ph: 601-815-6700
Montana
  Great Falls
 Big Sky Oncology
 Grant William Harrer Ph: 406-731-8217
New Jersey
  Paterson
 St. Joseph's Hospital and Medical Center
 Michael Maroules Ph: 973-754-2909
Washington
  Centralia
 Providence Centralia Hospital
 Yoshio Inoue Ph: 253-403-2394
  Federal Way
 St. Francis Hospital
 Yoshio Inoue Ph: 253-403-2394
  Olympia
 Providence St. Peter Hospital Regional Cancer Center
 Yoshio Inoue Ph: 253-403-2394
  Puyallup
 Good Samaritan Cancer Center
 Yoshio Inoue Ph: 253-403-2394
  Tacoma
 Allenmore Hospital
 Yoshio Inoue Ph: 253-403-2394
 CCOP - Northwest
 Yoshio Inoue Ph: 253-403-2394
 Franciscan Cancer Center at St. Joseph Medical Center
 Yoshio Inoue Ph: 253-403-2394
 MultiCare Regional Cancer Center at Tacoma General Hospital
 Yoshio Inoue Ph: 253-403-2394
 St. Clare Hospital
 Yoshio Inoue Ph: 253-403-2394

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00118209
ClinicalTrials.gov processed this data on October 17, 2013

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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