Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma
RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This randomized phase II trial studies how well combination chemotherapy given together with autologous stem cell transplant works compared to combination chemotherapy alone in treating patients with central nervous system B-cell lymphoma.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial of Myeloablative Versus Non-Myeloablative Consolidation Chemotherapy for Newly Diagnosed Primary CNS B-cell Lymphoma|
- Two-year PFS [ Time Frame: At 2 years ] [ Designated as safety issue: No ]
- EFS [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- Toxicity rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
- OS [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: Arm I (carmustine, thiotepa, filgrastim, transplant)
CONSOLIDATION THERAPY: Beginning 2-4 weeks after stem cell mobilization, patients receive high-dose therapy comprising carmustine IV over 2 hours on day -6 and thiotepa IV over 2 hours every 12 hours on days -5 to -4. Beginning on day 4, patients also receive filgrastim SC once a day and continuing until absolute neutrophil count recovers.
STEM CELL RESCUE: Patients then undergo autologous peripheral blood stem cell transplantation on day 0.
Given IVDrug: thiotepa
Given IVProcedure: transplant
Undergo autologous HSCTProcedure: filgrastim
Experimental: Arm II (cytarabine, etoposide and filgrastim)
Beginning at least 8 weeks after completion of induction therapy, patients receive cytarabine IV over 2 hours every 12 hours on days 1-4, and etoposide IV continuously over 96 hours on days 1-4. Beginning on day 14, patients also receive filgrastim SC once a day and continuing until absolute neutrophil count recovers.
Given IVDrug: etoposide
Given IVProcedure: filgrastim
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01511562
|Contact: Tracy Batchelor, MD, MPH||617-643-1938|
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|Study Chair:||Tracy Batchelor, MD, MPH||Massachusetts General Hospital|