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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2024-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Graft Versus Host Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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RUX group

Group Type EXPERIMENTAL

Ruxolitinib+Calcineurin inhibitor+Methotrexate

Intervention Type DRUG

low-dose ruxolitinib combine with calcineurin inhibitor and short course of methotrexate.

Control group

Group Type ACTIVE_COMPARATOR

Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil

Intervention Type DRUG

calcineurin inhibitor and short course of methotrexate and mycophenolate mofetil

Interventions

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Ruxolitinib+Calcineurin inhibitor+Methotrexate

low-dose ruxolitinib combine with calcineurin inhibitor and short course of methotrexate.

Intervention Type DRUG

Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil

calcineurin inhibitor and short course of methotrexate and mycophenolate mofetil

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No