Status:
RECRUITING
PTCy and and Ruxolitinib for GVHD Prophylaxis After HSCT With Thymoglobulin in Conditioning Regimen in Patients With Inborn Errors of Immunity
Lead Sponsor:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Conditions:
Inborn Errors of Immunity
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
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 i...
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 (PT...
Eligibility Criteria
Inclusion
- Patients aged ≥ 0 months and \< 21 years
- Patients diagnosed with NBS eligible for an allogeneic HSCT
- Signed written informed consent signed by a parent or legal guardian
Exclusion
- Concomitant severe somatic disease associated with an additional risk of severe complications
Key Trial Info
Start Date :
November 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06199427
Start Date
November 21 2023
End Date
December 31 2027
Last Update
January 10 2024
Active Locations (1)
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1
HSCT department
Moscow, Russia