Maraviroc-Based GVHD Prophylaxis in HLA-Unrelated and HLA-Mismatched Related Transplantation
Summary
HLA-mismatched unrelated donor (MMUD) and HLA-haploidentical donor (Haplo Donor) hematopoietic stem cell transplantation (HSCT) is associated with increased graft-versus-host-disease (GVHD) and impaired survival. The chemokine receptor 5 (CCR5) antagonist maraviroc has immunomodulatory properties potentially beneficial for GVHD control as it can blockade lymphocyte chemotaxis without impairing T-cell function. The aim of this study is to evaluate the safety and efficacy of maraviroc combined with standard graft-versus-host-disease prophylaxis in patients with hematologic malignancies after allogeneic stem cell transplantation from HLA-Unrelated or HLA-Mismatched Related donors. Based on the results of our previously small sample study with maraviroc combined with cyclosporine/tacrolimus and methotrexate for prophylaxis of GVHD, the investigators plan to perform the clinical trail.
Timeline
- Start
- 2014-04
- Primary completion
- 2016-12
- Completion
- 2017-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Maraviroc | Other / unclassified | 300 mg | Oral |
| Background | Cyclosporine | Peptide | 2 mg/kg | Intravenous |
| Background | Cyclosporine | Peptide | 3 mg/kg | Intravenous |
| Background | Methotrexate | Small molecule | 10 mg/m2 | Intravenous |
| Background | Tacrolimus | Small molecule | 0.03 mg/kg | Oral |
| Background | Tacrolimus | Small molecule | 0.05 mg/kg | Oral |