drugset / Trial / NCT01350245
Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor
Phase 2
Completed
28 enrolled
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
NaSingle-groupOpen-labelTreatment
Summary
The primary hypothesis of this research study is that patients in remission undergoing myeloablative haploidentical hematopoietic stem cell transplantation (HSCT) on the Thomas Jefferson University (TJU) 2 Step treatment regimen will have a disease-free survival (DFS) rate at 1 year that is the same or better than the historical DFS of patients with similar diagnoses and ages undergoing matched sibling HSCT. Based on a review of the literature a DFS rate of 50% or better at 1 year would meet the criterion for an effective alternative therapy. A DFS rate of 75% or better would imply superior efficacy of the TJU 2 Step approach over T-replete matched sibling HSCT.
Timeline
- Start
- 2010-07
- Primary completion
- 2013-05
- Completion
- 2014-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | — |
| Background | Mycophenolate Mofetil | Small molecule | — | — |
| Background | Tacrolimus | Small molecule | — | — |