Clinical Trials in China / NCT07576010
Active, not recruiting
Phase 1
Steroids Combined With Ruxolitinib as First-Line Therapy for Grade II Acute Graft-versus-Host Disease
NCT07576010 · tracked via the Priya Life Science China tracker
Condition(s) studied
Acute Graft-versus-host Disease
Investigational drug(s) / intervention(s)
RUX+Steroids
RUX+Steroids: Patients with acute grade II GVHD are treated with a combination of methylprednisolone (0.5 mg/kg/day) and ruxolitinib.
Study summary
This study aims to evaluate the efficacy and safety of low-dose corticosteroids combined with ruxolitinib in the treatment of grade II acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation.
Eligibility
Inclusion Criteria:
* Patients with malignant hematologic diseases eligible for allogeneic hematopoietic stem cell transplantation, including MDS-RAEB, acute leukemia, and chronic phase of CML.
* Availability of an HLA-matched sibling donor, unrelated donor, or haploidentical donor.
* Age ≥ 14 years.
* Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN), total bilirubin ≤ 2 × ULN.
* Renal function: serum creatinine ≤ ULN.
* Absence of uncontrolled infection or severe psychiatric/psychological disorders.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
* Signed informed consent.
* Diagnosis of grade II acute GVHD as assessed by the modified Glucksberg grading criteria for acute GVHD.
Exclusion Criteria:
* Absence of an allogeneic donor.
* Pregnancy of either the donor or the recipient.
* Presence of psychiatric disorders or other conditions that preclude compliance with the study protocol.
Primary outcome measure(s)
- Graft-Versus-Host Disease-Free, Relapse-Free Survival — 1 years after treatment
Graft-versus-host disease-free, relapse-free survival (GRFS) refers to the time from the start of treatment (or from transplantation) to the first occurrence of any of the following events: grade III-IV acute graft-versus-host disease (aGVHD), chronic graft-versus-host disease (cGVHD) requiring systemic immunosuppressive therapy, disease relapse or progression, or death from any cause.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality |
More Daihong Liu trials in China
Other trials for the same condition
Tissue-resident Immune Cell Subsets in aGVHD
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07576010 on ClinicalTrials.gov ↗ ← All trials in China