Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive B-Cell Diffuse Large Cell Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 to 70 NCI ECOG-E2499 CALGB-50205, CALGB-E2499, NCT00052923, E2499

Objectives

1. Compare disease-free survival of patients with relapsed or progressive B-cell diffuse large cell lymphoma undergoing stem cell transplantation with or without post-transplant rituximab.
2. Evaluate the effect of rituximab, administered post-transplant, on the procedure-related mortality of these patients.
3. Determine the potential infectious complications of the addition of this drug to autologous stem cell transplantation in these patients.
4. Compare overall survival of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Diagnosis of diffuse large cell lymphoma and meeting the following criteria:
  • B-cell type with expression of CD20 either at diagnosis or at relapse
  • Relapse after having achieved an initial complete remission (CR) or failure to achieve initial CR (residual radiographic abnormalities after primary therapy allowed if these abnormalities are also positive by positron emission tomography or MRI [gallium])
  • No newly diagnosed disease



• No progressive or stable disease to most recent salvage therapy

Prior/Concurrent Therapy:

Biologic therapy

• See Chemotherapy
• No more than 3 prior immunotherapy regimens

Chemotherapy

• No more than 3 prior chemotherapy regimens
  • Addition of radiation or a monoclonal antibody to chemotherapy is considered one treatment regimen if the addition was part of the initial treatment plan
  • Addition of these therapies due to lack of response or poor response would be considered an additional treatment regimen whether given in front-line or salvage setting

Endocrine therapy

• Not specified

Radiotherapy

• See Chemotherapy
• No more than 3 prior radiotherapy regimens
• No prior radioimmunotherapy

Surgery

• Not specified

Patient Characteristics:

Age

• 18 to 70

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³

Hepatic

• Bilirubin ≤ 2.0 mg/dL
• AST or ALT < 3 times upper limit of normal

Renal

• Creatinine ≤ 2.0 mg/dL

  OR

• Creatinine clearance ≥ 40 mL/min

Cardiovascular

• Cardiac ejection fraction ≥ 40%

Pulmonary

• DLCO ≥ 60% of predicted

Other

• No other malignancy within the past 2 years except basal cell skin cancer or carcinoma in situ of the cervix
• No active infection requiring oral or IV antibiotics
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 427 patients will be accrued for this study within 3.5 years.

Outcomes

Progression-free survival

Procedure-related mortality
Overall survival
Potential infectious complications of the addition of rituximab to autologous stem cell transplantation

Outline

This is a randomized, multicenter study. Patients are stratified according to relapse (relapsed more than 6 months after either initial complete remission [CR] or CR with positive positron emission tomography or MRI [gallium] vs failed to achieve initial CR or relapsed within 6 months after either initial CR or CR with positive PET or MRI [gallium]) and prior rituximab (yes vs no).

Stem cell mobilization

• Patients receive rituximab IV over 4-8 hours on days 1 and 5. Patients also receive cyclophosphamide IV over 2 hours on day 8 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until the last day of apheresis. Stem cells are collected over 1-3 days.

Preparative regimen

• Regimen A (patients who have received prior radiotherapy or are ≥ 61 years of age): Patients receive carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on day -2.



• Regimen B (all other patients): Patients undergo total body irradiation twice daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2.

Stem cells are reinfused on day 0. Patients are then randomized to one of two post-transplant treatment arms.

Post-transplant treatment

• Arm I (rituximab): Patients receive G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients receive rituximab IV over 4-8 hours every 7 days for 4 doses, starting on day 45 post-transplant. Course of rituximab is repeated beginning on day 180 post-transplant.
• Arm II (no rituximab): Patients receive G-CSF as in arm I.

Patients are followed for 10 years.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Ian Flinn, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 410-614-5542 Email: iflinn@jhmi.edu

Cancer and Leukemia Group B

Charles Linker, MD, Protocol chair		Ph: 415-353-2737; 800-888-8664 Email: linkerc@medicine.ucsf.edu

Registry Information
Official Title		Randomized Phase III Trial Of Rituximab (NSC #687451) And Autologous Stem Cell Transplantation For B Cell Diffuse Large Cell Lymphoma
Trial Start Date		2003-03-04
Registered in ClinicalTrials.gov		NCT00052923
Date Submitted to PDQ		2002-11-06
Information Last Verified		2006-06-01
NCI Grant/Contract Number		CA21115

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