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

Study Overview
=================
Brief Summary
-----------------
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.

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 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.

Official Title
-----------------
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

Conditions
-----------------
Graft Versus Host Disease

Intervention / Treatment
-----------------
* Drug: Ruxolitinib+Calcineurin +Methotrexate
* Drug: Calcineurin +Methotrexate+Mycophenolate mofetil


Participation Criteria
=================
Eligibility Criteria
-----------------
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. 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: 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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RUX group<br> | Drug: Ruxolitinib+Calcineurin +Methotrexate<br>* low-dose ruxolitinib combine with calcineurin and short course of methotrexate.<br>|
| Active Comparator: Control group<br> | Drug: Calcineurin +Methotrexate+Mycophenolate mofetil<br>* calcineurin and short course of methotrexate and mycophenolate mofetil<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100-day cumulative II-IV aGVHD incidence after HSCT | 100-day cumulative II-IV aGVHD incidence after HSCT | 100-day after HSCT through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative cGVHD incidence | cGVHD incidence after HSCT | Time after HSCT through study completion, an average of 1 year | 
| overall survival | overall survival after HSCT | Time after HSCT through study completion, an average of 1 year | 
| adverse effects | drug related adverse effects | Time after intervention through study completion, an average of 1 year | 
| cumulative incidence of relapse after HSCT | cumulative incidence of relapse after HSCT | Time after HSCT through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Graft Versus Host Disease, ruxolitinib, HLA-haploidentical hematopoietic stem cell transplantation