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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

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ClinicalTrials.gov Identifier: NCT04838704
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
He Huang, Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Graft Versus Host Disease Drug: Ruxolitinib+Calcineurin +Methotrexate Drug: Calcineurin +Methotrexate+Mycophenolate mofetil Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : April 8, 2021
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2025


Arm Intervention/treatment
Experimental: RUX group Drug: Ruxolitinib+Calcineurin +Methotrexate
low-dose ruxolitinib combine with calcineurin and short course of methotrexate.

Active Comparator: Control group Drug: Calcineurin +Methotrexate+Mycophenolate mofetil
calcineurin and short course of methotrexate and mycophenolate mofetil




Primary Outcome Measures :
  1. 100-day cumulative II-IV aGVHD incidence after HSCT [ Time Frame: 100-day after HSCT through study completion, an average of 1 year ]
    100-day cumulative II-IV aGVHD incidence after HSCT


Secondary Outcome Measures :
  1. cumulative cGVHD incidence [ Time Frame: Time after HSCT through study completion, an average of 1 year ]
    cGVHD incidence after HSCT

  2. overall survival [ Time Frame: Time after HSCT through study completion, an average of 1 year ]
    overall survival after HSCT

  3. adverse effects [ Time Frame: Time after intervention through study completion, an average of 1 year ]
    drug related adverse effects

  4. cumulative incidence of relapse after HSCT [ Time Frame: Time after HSCT through study completion, an average of 1 year ]
    cumulative incidence of relapse after HSCT



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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04838704


Contacts
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Contact: Yanmin Zhao, PhD +8615858199217 zjzhaoyanmin@163.com

Locations
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China, Zhejiang
The First Hospital of Zhejiang Medical Colleage Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Yanmin Zhao, PhD    +8615858199217    zjzhaoyanmin@163.com   
Sponsors and Collaborators
Zhejiang University
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Responsible Party: He Huang, Professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT04838704    
Other Study ID Numbers: RCMvsCM
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by He Huang, Zhejiang University:
Graft Versus Host Disease
ruxolitinib
HLA-haploidentical hematopoietic stem cell transplantation
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Mycophenolic Acid
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents