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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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07576010). StuddyBuddy aggregates publicly available trial information.