Clinical Trial: Trial of GVHD Prophylasxis With PTCy or Thymoglobulin in Unrelated SCT

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized Trial of GVHD Prophylasxis With Post-transplantation Cyclophocphomide (PTCy) or Thymoglobulin in Unrelated SCT Recepients With Chronic Myeloproliferative Neoplasms and Myelodisplatic Syndro

Brief 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.

Detailed Summary:
Sponsor: St. Petersburg State Pavlov Medical University

Current Primary Outcome: Incidence of primary graft failure [ Time Frame: 60 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of acute GVHD, grades II-IV [ Time Frame: 365 days ]
  • Incidence of chronic GVHD, moderate and severe (NIH criteria) [ Time Frame: 365 days ]
  • Non-relapse mortality analysis [ Time Frame: 365 days ]
  • Event-free survival analysis [ Time Frame: 365 days ]
  • Overall survival analysis [ Time Frame: 365 days ]
  • Relapse rate analysis [ Time Frame: 365 days ]
  • Toxicity (NCI CTCAE 4.03) [ Time Frame: 100 days ]
    Toxicity parameters based on NCI CTCAE 4.03 grades: hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), mucositis (attending physician assessment), hemorrhagic cystitis (attending physician assessment), cardiotoxicity (ECG, echocardiography). Additional toxicity parameters: incidence and severity of veno-occlusive disease, incidence of transplant-associated microangiopathy
  • Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence [ Time Frame: 100 days ]


Original Secondary Outcome: Same as current

Information By: St. Petersburg State Pavlov Medical University

Dates:
Date Received: December 4, 2015
Date Started: July 2015
Date Completion: July 2017
Last Updated: December 14, 2016
Last Verified: December 2016