Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06199427
Status:
RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-12-28
Brief Title:
PTCy and and Ruxolitinib for GVHD Prophylaxis After HSCT With Thymoglobulin in Conditioning Regimen in Patients With Inborn Errors of Immunity
Sponsor:
Federal Research Institute of Pediatric Hematology Oncology and Immunology
Organization:
Federal Research Institute of Pediatric Hematology Oncology and Immunology
Study Overview
Official Title:
Safety and Efficacy of Cyclophosphamide and Ruxolitinib for Graft-versus-host-disease Prophylaxis After Hematopoietic Stem Cell Transplantation With Thymoglobulin Serotherapy in Conditioning Regimen in Patients With Inborn Errors of Immunity
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the current study is to evaluate the efficacy of combined regimen of GVHD prophylaxis with thymoglobulin in conditioning regimen and PTCY with ruxolitinib used after HSCT in patients with inborn errors of immunity IEI
Detailed Description:
Hematopoietic stem cell transplantation HSCT is widely used in inborn errors of immunity IEI and risks of graft-versus-host disease GVHD remain high Use of post-transplant cyclophosphamide PTCY for GVHD prophylaxis revolutionized the outcomes of HSCT from mismatched related donor MMRD Use of ruxolitinib for GVHD prophylaxis demonstrates promising results in adult patients Another well-known option for GVHD prevention is antithymocyte globulin To evaluate the efficacy of combination of thymoglobulin with PTCY and ruxolitinib for GVHD prophylaxis conditioning regimen containing treosulfan 30-42 gm2 fludarabine 150 mgmg and thiotepa 10 mgkg or melphalan 140 mgm2 and GVHD prophylaxis regimen containing cyclophosphamide 50 mgkg for MMRD 25 mgkg for matched unrelated and related donors at days 3 4 post-HSCT and ruxolitinib at dose 7 mgm2 from day 5 after HSCT will be used in patients with IEI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None