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

  • STATUS
    Recruiting
  • End date
    Jan 31, 2025
  • participants needed
    206
  • sponsor
    Zhejiang University
Updated on 16 April 2021

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.

Details
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

Eligibility

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note