Trial of GVHD Prophylasxis With PTCy or Thymoglobulin in Unrelated SCT
Summary
Purpose There is a growing evidence of high efficacy of post-transplantation cyclophocphomide (PTCy)-based GVHD prophylaxis in haploidentical and matched related and unrelated bone marrow transplantation. There is limitted, but growing data on safety and efficacy of this prophylaxis in unrelated and peripheral blood stem cell transplantations. Use of PTCy in chronic myeloproliferative neoplasms and myelodisplatic syndrome is of particular interest. On the one hand, PTCy could reduce the incidence of chronic GVHD and long-term bormidity. On the other hand, there is a concern, that PTCy can increase the incidence of graft failures in this group of patients. Currently published data indicate that low-dose Thymoglobulin-based prophylaxis is the most promissing compatitor in terms of acute and chronic GVHD control. So there is a rationale to randomize Thymoglobulin and PTCy as GVHD prophilaxis. Pre-transplant assesment of moratlity (PAM)-index will be used as the strata for randomization, as it is the paramter that takes into account the most important factors effecting survival. The conditioning regimen and the other two components of GVHD prophylaxis (mycophenolate mofetil and tacrolimus) will be identical in the two arms of the study.
Timeline
- Start
- 2015-07
- Primary completion
- 2019-04-03
- Completion
- 2019-04-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |
| Subject | Thymoglobulin | Protein / enzyme biologic | 2.5 mg/kg | Oral |
| Background | Busulfan | Small molecule | 1 mg/kg | Oral |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 30 mg/kg | Intravenous |
| Background | Tacrolimus | Small molecule | 0.03 mg/kg | — |