Ignite Creation Date:
2024-05-06 @ 7:53 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02627573
Status:
TERMINATED
Last Update Posted:
2019-04-05
First Post:
2015-12-04
Brief Title:
Trial of GVHD Prophylasxis With PTCy or Thymoglobulin in Unrelated SCT
Sponsor:
St Petersburg State Pavlov Medical University
Organization:
St Petersburg State Pavlov Medical University
Study Overview
Official Title:
Randomized Trial of GVHD Prophylasxis With Post-transplantation Cyclophocphomide PTCy or Thymoglobulin in Unrelated SCT Recepients With Chronic Myeloproliferative Neoplasms and Myelodisplatic Syndrome
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None