drugset / Trial / NCT06001385
HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis
Phase 2
Active not recruiting
313 enrolled
Center for International Blood and Marrow Transplant Research
National Marrow Donor Program · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to determine the effectiveness of Reduced Dose Post-Transplant Cyclophosphamide (PTCy) in patients with hematologic malignancies after receiving an HLA-Mismatched Unrelated Donor (MMUD) . The main question\[s\] it aims to answer are: * Does a reduced dose of PTCy reduce the occurrence of infections in the first 100 days after transplant? * Does a reduced dose of PTCy maintain the same level of protection against Graft Versus Host Disease (GvHD) as the standard dose of PTCy?
Timeline
- Start
- 2023-12-08
- Primary completion
- 2026-02-01
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Cyclophosphamide | Other / unclassified | 25 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 37.5 mg/kg | Intravenous |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | — | Intravenous |
| Background | Busulfan | Small molecule | 6.4 mg/kg | Intravenous |
| Background | Busulfan | Small molecule | 8 mg/kg | Intravenous |
| Background | Busulfan | Small molecule | 9 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 29 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 90 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 125 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 150 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 180 mg/m2 | Intravenous |
| Background | Melphalan | Small molecule | 100 mg/m2 | Intravenous |
| Background | Melphalan | Small molecule | 140 mg/m2 | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 15 mg/kg | Intravenous |
| Background | Tacrolimus | Small molecule | 0.03 mg/kg | Oral |
| Background | Tacrolimus | Small molecule | 0.05 mg/kg | Oral |