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Completed

NCT Number: NCT04838704

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

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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Key information

Conditions

Graft Versus Host Disease Graft vs Host Disease Immune System Diseases

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Zhejiang Medical Colleage Zhejiang University

Hangzhou, Zhejiang, 310006, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ruxolitinib+Calcineurin inhibitor+Methotrexate

Drug

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

Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil

Drug

calcineurin inhibitor and short course of methotrexate and mycophenolate mofetil

Primary outcomes

  1. 100-day cumulative II-IV aGVHD incidence after HSCT

    Time frame: From the date of transplantation to the first occurrence of grade II-IV acute GVHD, assessed up to 100 days.

    Cumulative incidence of grade II-IV acute GVHD occurring within the first 100 days following transplantation.

Secondary outcomes

  1. Cumulative Incidence of Chronic GVHD

    Time frame: From the date of transplantation to the first diagnosis of chronic GVHD, assessed up to 3 years.

    The cumulative incidence of chronic GVHD following transplantation.n

  2. Overall Survival

    Time frame: From the date of transplantation until death from any cause, assessed up to 3 years.

    Overall survival following is defined as the time from transplantation to death from any cause.

  3. Adverse Events

    Time frame: From the date of transplantation to day 180 post-transplantation.

    Incidence and type adverse events following transplantation.

  4. Cumulative Incidence of Relapse

    Time frame: From the date of transplantation to the first documented relapse, assessed up to 3 years.

    Cumulative incidence of disease relapse following transplantation is defined as the time from transplantation to the first documented disease recurrence.

  5. GVHD-Free, Relapse-Free Survival

    Time frame: From the date of transplantation to the first occurrence of grade III-IV acute GVHD, systemic therapy-requiring chronic GVHD, relapse, or death, assessed up to 3 years.

    GVHD-free, relapse-free survival is defined as the time from transplantation to the first occurrence of grade III-IV acute GVHD, chronic GVHD requiring systemic therapy, disease relapse, or death from any cause.

  6. Non-Relapse Mortality

    Time frame: From the date of transplantation to death without prior relapse or disease progression, assessed up to 3 years.

    Non-relapse mortality is defined as death without evidence of relapse or progression of the primary disease following transplantation.

  7. Relapse-Free Survival

    Time frame: From the date of transplantation to the first documented relapse or death from any cause, assessed up to 3 years.

    Relapse-free survival is defined as the time from transplantation to the first documented relapse of the underlying disease or death from any cause.

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Collaborators

  • Ruijin Hospital
  • The Children's Hospital of Zhejiang University School of Medicine
  • The First Affiliated Hospital of Zhengzhou University
  • Yinzhou Hospital Affiliated to Medical School of Ningbo University

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2021
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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