Overview

This trial is active, not recruiting.

Condition lymphoma
Treatments filgrastim, rituximab, sargramostim, carmustine, cyclophosphamide, etoposide, adjuvant therapy, bone marrow ablation with stem cell support, peripheral blood stem cell transplantation
Phase phase 2
Target CD20
Sponsor Sidney Kimmel Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date March 2004
End date January 2015
Trial size 44 participants
Trial identifier NCT00242996, CDR0000447158 J0376, JHOC-J0376, P30CA006973, WIRB-20040009

Summary

RATIONALE: Giving colony-stimulating factors, such as G-CSF, monoclonal antibodies, such as rituximab, and chemotherapy, such as cyclophosphamide, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for peripheral stem cell transplant. Giving chemotherapy, such as carmustine, etoposide, and cyclophosphamide, before transplant stops the growth of cancer cells by stopping them from dividing or killing them. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. More rituximab is given after transplant to kill any remaining cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with cyclophosphamide and G-CSF followed by combination chemotherapy works in treating patients undergoing an autologous stem cell transplant followed by rituximab and GM-CSF for refractory diffuse large B-cell lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
2-year event free survival
time frame:

Secondary Outcomes

Measure
Overall survival
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

DISEASE CHARACTERISTICS: - Diagnosis of diffuse large B-cell lymphoma, meeting 1 of the following criteria: - Failed to achieve at least partial remission - Failed to respond to prior primary therapy or salvage chemotherapy - Disease progression within 6 weeks after achieving remission - CD20 expression at diagnosis or relapse - No more than 4 prior regimens using chemotherapy, radiotherapy, or immunotherapy - The addition of radiotherapy or a monoclonal antibody to chemotherapy is considered 1 treatment regimen provided the addition was part of the initial treatment plan - The addition of these therapies due to lack of response or poor response is considered an additional treatment regimen whether given in the front line or salvage setting PATIENT CHARACTERISTICS: Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,000/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic - Direct bilirubin ≤ 2 mg/dL - AST or ALT < 3 times upper limit of normal Renal - Creatinine ≤ 2.0 mg/dL Cardiovascular - Ejection fraction ≥ 40% Pulmonary - DLCO ≥ 60% of predicted Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No active infection requiring oral or IV antibiotics - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - See Radiotherapy Chemotherapy - See Disease Characteristics Radiotherapy - See Disease Characteristics - No prior radioimmunotherapy

Additional Information

Official title Phase II Trial of Rituximab and Autologous Stem Cell Transplantation for Refractory B Cell Large Cell Lymphoma
Description OBJECTIVES: - Determine the disease-free and overall survival of patients with refractory diffuse large B-cell lymphoma treated with stem cell mobilization comprising rituximab, cyclophosphamide, and filgrastim (G-CSF) followed by high-dose chemotherapy comprising carmustine, etoposide, and cyclophosphamide and autologous peripheral blood stem cell transplantation, rituximab, and sargramostim (GM-CSF). - Determine any potential infectious complications in patients treated with this regimen. - Determine the effect of GM-CSF on antibody-dependent cellular cytotoxicity in patients treated with this regimen. OUTLINE: Stem cell mobilization: Patients receive rituximab IV over 4-8 hours on days 1, 5, 8, and 13. Patients also receive cyclophosphamide IV over 1-2 hours on day 9 and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 10 and continuing until an adequate number of peripheral blood stem cells (PBSC) are collected. High-dose preparative regimen: 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. Autologous PBSC transplantation: Patients undergo autologous PBSC transplantation on day 0. Patients receive sargramostim (GM-CSF) SC once daily beginning on day 6 and continuing until blood counts recover. Post-transplant regimen: Patients receive GM-CSF SC once daily on days 42-73, 177-208, 362-393, 543-574, and 727-758. Patients also receive rituximab IV over 4-8 hours on days 45, 52, 59, 66, 180,187, 194, 201, 365, 372, 379, 386, 546, 553, 560, 567, 730, 737, 744, and 751. After completion of study treatment, patients are followed periodically for 10 years. PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.