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Active Not Recruiting
NCT07576010
Steroids Combined With Ruxolitinib as First-Line Therapy for Grade II Acute Graft-versus-Host Disease
Conditions: Acute Graft-versus-host Disease
Sex: All
Ages: N/A – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 30
Sponsor: Daihong Liu
Location: Chinese PLA General Hospital Beijing Beijing Municipality
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07576010). StuddyBuddy aggregates publicly available trial information.