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

Zhejiang University

Status: Completed

Conditions: Graft Versus Host Disease

Treatments: Drug: Ruxolitinib+Calcineurin inhibitor+Methotrexate; Drug: Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil

Study type: Interventional

Funder types: Other

Identifiers

NCT04838704

RCMvsCM

Details and patient eligibility

About

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 hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system.

Full 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 inhibitor 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.

Enrollment: 215 patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must be diagnosed with malignant hematological disease.
2. aged 12-70 years.
3. Received HLA-haploidentical hematopoietic stem cell transplantation.
4. received myeloablative conditioning
5. Karnofsky score ≥70.
6. 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 criteria

1. Active autoimmune disease, such as SLE, rheumatoid arthritis, etc.
2. 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.
3. Other serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes).
4. human immunodeficiency virus (HIV) infection.
5. cirrhosis of the liver, active hepatitis.
6. Pregnant or lactating women.
7. Patients who are concurrently enrolled in any clinical trials of similar drugs.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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215 participants in 2 patient groups

RUX group

Experimental group

Treatment:

Drug: Ruxolitinib+Calcineurin inhibitor+Methotrexate

Control group

Active Comparator group

Treatment:

Drug: Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil