Ruxolitinib With Calcineurin and Methotrexate vs. Calcineurin Plus Methotrexate and Mycophenolate Mofetil as Graft Versus Host Disease Prophylaxis for HLA-haploidentical Hematopoietic Stem Cell Transplantation

  • End date
    Jan 31, 2025
  • participants needed
  • sponsor
    Zhejiang University
Updated on 16 April 2021


Low Dose Ruxolitinib with Calcineurin and Methotrexate vs. Calcineurin plus Methotrexate and Mycophenolate mofetil as Graft Versus Host Disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system.


The is a prospective, randomized two-arm, and multicenter study. To compare the efficacy and safety of low-dose ruxolitinib combined with calcineurin and methotrexate vs. calcineurin plus methotrexate and mycophenolate mofetil as graft versus host disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system.

Condition Graft-Versus-Host Disease, Graft-Versus-Host Disease (GVHD), graft versus host disease, graft-versus-host-disease
Treatment Ruxolitinib+Calcineurin +Methotrexate, Calcineurin +Methotrexate+Mycophenolate mofetil
Clinical Study IdentifierNCT04838704
SponsorZhejiang University
Last Modified on16 April 2021


Yes No Not Sure

Inclusion Criteria

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
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 Criteria

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
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