drugset / Trial / NCT00912223
Blood Stem Cell Transplant With Low Dose Chemotherapy for Relapsed Follicular Non-Hodgkin's Lymphoma (BMT CTN 0701)
Phase 2
Completed
65 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
NaSingle-groupOpen-labelTreatment
Summary
Blood stem cell transplants are one treatment option for people with lymphoma or other types of blood cancers. For this type of treatment, family members or unrelated donors with a similar tissue type usually donate their blood stem cells to the transplant patients. This study will evaluate the effectiveness of a type of blood stem cell transplant that uses lower doses of chemotherapy in people with relapsed follicular non-Hodgkin's lymphoma (NHL).
Timeline
- Start
- 2009-04
- Primary completion
- 2014-11
- Completion
- 2016-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | — |
| Background | Methotrexate | Small molecule | 5 mg/m2 | — |
| Background | NOTE: The - sign is the number of days before the transplant and the + sign is the number of days after the transplant. The conditioning regimen will consist of the following: * Rituxan 375 mg/m\^2 on Day -13 * Rituxan 1000 mg/m\^2 on Days -6, +1, and +8 * Fludarabine 30 mg/m\^2 on Days -5 to -3 * Cyclophosphamide 750 mg/m\^2 on Days -5, -4, -3 Day 0 will be the day of the transplant. The GVHD prophylaxis will consist of the following: * Tacrolimus .09 mg/kg/po (Day -2 thru Day +180). Doses will be adjusted to maintain blood levels of 5-15 ng/mL. * Methotrexate 5 mg/m\^2 (Days +1, +3, and +6). Unrelated donor recipients will receive a fourth dose on Day +11. | Unknown | 1000 mg/m2 | — |
| Background | Tacrolimus | Small molecule | 0.09 mg/kg | Oral |