Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
- Conditions
- Lymphoma
- Interventions
- Biological: filgrastimBiological: rituximabProcedure: peripheral blood stem cell transplantation
- Registration Number
- NCT00020943
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and rituximab with peripheral stem cell transplantation in treating patients who have mantle cell lymphoma.
- Detailed Description
OBJECTIVES:
* Determine the two-year progression-free survival of patients with mantle cell lymphoma treated with intensive chemotherapy and rituximab with autologous peripheral blood stem cell (PBSC) transplantation.
* Determine the complete and partial response rates of patients treated with this regimen.
* Determine the disease-free and overall survival of patients treated with this regimen.
* Determine the autologous immune reconstitution in patients treated with this regimen.
* Determine the feasibility of this regimen in this patient population.
* Determine whether treatment with rituximab during autologous PBSC transplantation reduces the amount of contaminating lymphoma in the autologous PBSC product.
OUTLINE: This is a multicenter study.
Patients receive induction therapy comprising rituximab IV over 4-6 hours on day 1; methotrexate IV over 4 hours on day 2; cyclophosphamide IV over 2 hours, doxorubicin IV, and vincristine IV on day 3; and oral prednisone on days 3-7. Patients also receive leucovorin calcium IV every 6 hours beginning on day 3 and continuing until blood levels of methotrexate are safe. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning on day 4 and continuing until blood counts recover.
Induction therapy repeats every 21-28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Rituximab may be omitted during course 1 if circulating mantle cells are excessive. Patients may receive a third course if more than 15% persistent bone marrow involvement is documented.
Patients with stable or responding disease begin consolidation therapy 29 days after the start of the final course of induction therapy. Patients receive cytarabine IV over 2 hours twice daily and etoposide IV over 96 hours on days 1-4. Patients also receive rituximab IV over 4-6 hours on days 5 or 6 and 12 or 13 and G-CSF SC beginning on day 14 and continuing until leukapheresis is complete. Patients undergo leukapheresis beginning between days 22-25 and continuing until adequate CD34 cells are collected.
Beginning 4 weeks after recovery from consolidation therapy, patients receive high-dose therapy comprising 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. Patients undergo autologous peripheral blood stem cell (PBSC) transplantation on day 0. Patients receive G-CSF SC beginning on day 6 and continuing until blood counts recover.
After blood counts recover and more than 35 days after autologous PBSC transplantation, patients receive rituximab IV over 4-6 hours weekly for 2 weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for up to 10 years.
PROJECTED ACCRUAL: At least 45 patients will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemo/immuno/autolog transplant rituximab Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma Chemo/immuno/autolog transplant carmustine Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma Chemo/immuno/autolog transplant filgrastim Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma Chemo/immuno/autolog transplant vincristine sulfate Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma Chemo/immuno/autolog transplant leucovorin calcium Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma Chemo/immuno/autolog transplant peripheral blood stem cell transplantation Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma Chemo/immuno/autolog transplant methotrexate Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma Chemo/immuno/autolog transplant cyclophosphamide Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma Chemo/immuno/autolog transplant cytarabine Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma Chemo/immuno/autolog transplant doxorubicin hydrochloride Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma Chemo/immuno/autolog transplant etoposide Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma Chemo/immuno/autolog transplant prednisone Intensive chemotherapy followed by autologous stem cell transplant and immunotherapy for mantle cell lymphoma
- Primary Outcome Measures
Name Time Method Progression Free Survival 2 years
- Secondary Outcome Measures
Name Time Method Response 2 years Survival 5 years Disease free and overall survival
Trial Locations
- Locations (81)
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Veterans Affairs Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Naval Medical Center - San Diego
🇺🇸San Diego, California, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
Hematology/Oncology Faculty Practice
🇺🇸San Francisco, California, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Scroll for more (71 remaining)Northeast Alabama Regional Medical Center🇺🇸Anniston, Alabama, United States