Status:
COMPLETED
Ruxolitinib With Calcineurin Inhibitor and Methotrexate vs. Calcineurin Inhibitor Plus Methotrexate and Mycophenolate Mofetil as Graft Versus Host Disease Prophylaxis for HLA-haploidentical Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
The Children's Hospital of Zhejiang University School of Medicine
Yinzhou Hospital Affiliated to Medical School of Ningbo University
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
12-70 years
Phase:
NA
Brief Summary
Low Dose Ruxolitinib with Calcineurin Inhibitor and Methotrexate vs. Calcineurin Inhibitor plus Methotrexate and Mycophenolate mofetil as Graft Versus Host Disease prophylaxis for HLA-haploidentical h...
Detailed Description
The is a prospective, randomized two-arm, and multicenter study. To compare the efficacy and safety of low-dose ruxolitinib combined with calcineurin inhibitor and methotrexate vs. calcineurin inhibit...
Eligibility Criteria
Inclusion
- Patients must be diagnosed with malignant hematological disease.
- aged 12-70 years.
- Received HLA-haploidentical hematopoietic stem cell transplantation.
- received myeloablative conditioning
- Karnofsky score ≥70.
- creatinine clearance ≥60 mL/min (according to the Cockcroft-Gault formula). (7) liver and kidney function: aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of the normal range (ULN), total bilirubin ≤ 2 × ULN; serum creatinine ≤ 1.5 × ULN.
- 8\) left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography (ECHO). 9) life expectancy \>12 weeks. 10) Voluntarily signed the consent form and could understand and comply with the requirements of the study.
Exclusion
- Active autoimmune disease, such as SLE, rheumatoid arthritis, etc.
- Current clinically significant active cardiovascular disease such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by New York Heart Association (NYHA) functional class, or a history of myocardial infarction within 6 months prior to enrollment.
- Other serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes).
- human immunodeficiency virus (HIV) infection.
- cirrhosis of the liver, active hepatitis.
- Pregnant or lactating women.
- Patients who are concurrently enrolled in any clinical trials of similar drugs.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT04838704
Start Date
April 1 2021
End Date
December 1 2024
Last Update
June 4 2025
Active Locations (1)
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1
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China, 310006