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

Graft Versus Host Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04838704
• Other study ID #: RCMvsCM
• Status: Recruiting
• Phase: Phase 4
• Start date: April 8, 2021
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2021
• Source: Zhejiang University
• Contact: Yanmin Zhao, PhD
• Phone: +8615858199217
• Email: zjzhaoyanmin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• Ruxolitinib+Calcineurin +Methotrexate
low-dose ruxolitinib combine with calcineurin and short course of methotrexate.
• Calcineurin +Methotrexate+Mycophenolate mofetil
calcineurin and short course of methotrexate and mycophenolate mofetil

Locations

Country	Name	City	State
China	The First Hospital of Zhejiang Medical Colleage Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	cumulative cGVHD incidence	cGVHD incidence after HSCT	Time after HSCT through study completion, an average of 1 year
Secondary	overall survival	overall survival after HSCT	Time after HSCT through study completion, an average of 1 year
Secondary	adverse effects	drug related adverse effects	Time after intervention through study completion, an average of 1 year
Secondary	cumulative incidence of relapse after HSCT	cumulative incidence of relapse after HSCT	Time after HSCT through study completion, an average of 1 year