drugset / Trial / NCT02793544
HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide
Phase 2
Completed
80 enrolled
Center for International Blood and Marrow Transplant Research
National Marrow Donor Program · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a multi-center, single arm Phase II study of hematopoietic cell transplantation (HCT) using human leukocyte antigen (HLA)-mismatched unrelated bone marrow transplantation donors and post-transplantation cyclophosphamide (PTCy), sirolimus and mycophenolate mofetil (MMF) for graft versus host disease (GVHD) prophylaxis in patients with hematologic malignancies.
Timeline
- Start
- 2016-12
- Primary completion
- 2020-03
- Completion
- 2020-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Busulfan | Small molecule | 9 mg/kg | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | 14.5 mg/kg | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |
| Comparator | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Comparator | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 80 % | Intravenous |
| Comparator | Mycophenolate Mofetil | Small molecule | 15 mg/kg | Oral |
| Comparator | Sirolimus | Small molecule | 1 mg/m2 | Oral |
| Comparator | Sirolimus | Small molecule | 2 mg | Oral |
| Comparator | filgrastim | Protein / enzyme biologic | 5 ug/kg | Intravenous |