drugset / Trial / NCT00096460
Autologous or Donor Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma (BMT CTN 0202)
Phase 2/3
Terminated
30 enrolled
Medical College of Wisconsin
Blood and Marrow Transplant Clinical Trials Network · collabNational Cancer Institute (NCI) · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabNational Marrow Donor Program · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is designed as a Phase II/III, multi-center trial, comparing two transplant strategies to determine whether non-myeloablative allogeneic Hematopoietic Stem Cell Transplantation (HSCT) will improve long-term progression-free survival compared to autologous HSCT. Recipients will be biologically assigned to the appropriate treatment arm depending on the availability of a Human Leukocyte Antigen (HLA) matched sibling.
Timeline
- Start
- 2004-08
- Primary completion
- 2006-03
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 100 mg/kg | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | 4 g | Intravenous |
| Subject | Etoposide | Small molecule | 60 mg/kg | Intravenous |
| Comparator | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | carmustine | Small molecule | 15 mg/kg | Intravenous |
| Comparator | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
| Comparator | filgrastim | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |
| Comparator | Methotrexate | Small molecule | 5 mg/m2 | Intravenous |
| Comparator | Tacrolimus | Small molecule | 0.09 mg/kg | Oral |