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PTCy and and Ruxolitinib for GVHD Prophylaxis After HSCT With Thymoglobulin in Conditioning Regimen in Patients With Inborn Errors of Immunity

NCT06199427 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-01-10

No results posted yet for this study

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)

Conditions

  • Inborn Errors of Immunity

Interventions

DRUG

Cyclophosphamide

Cyclophosphamide 25mg/kg (days +3, +4) after HSCT from MUD and MRD Cyclophosphamide 50mg/kg (days +3, +4) after HSCT from MMRD

DRUG

Ruxolitinib

Ruxolitinib 7 mg/m2 from day +5 after HSCT

Sponsors & Collaborators

  • Federal Research Institute of Pediatric Hematology, Oncology and Immunology

    lead OTHER

Principal Investigators

  • Dmitry Balashov, MD, PhD · National Research Center for Pediatric Hematology, Moscow, Russia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-21
Primary Completion
2026-11-21
Completion
2027-12-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06199427 on ClinicalTrials.gov