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

NCT04838704 | Completed DMC

• 1 other identifier: RCMvsCM
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Graft Versus Host Disease

Keywords

Graft Versus Host Disease; ruxolitinib; HLA-haploidentical hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• 100-day cumulative II-IV aGVHD incidence after HSCT

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

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

Secondary Outcomes (7)

• Cumulative Incidence of Chronic GVHD

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

• Overall Survival

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

• Adverse Events

  From the date of transplantation to day 180 post-transplantation.

• Cumulative Incidence of Relapse

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

• GVHD-Free, Relapse-Free Survival

  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.

Study Arms (2)

RUX group

EXPERIMENTAL

Drug: Ruxolitinib+Calcineurin inhibitor+Methotrexate

Control group

ACTIVE COMPARATOR

Drug: Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil

Interventions

Ruxolitinib+Calcineurin inhibitor+Methotrexate DRUG

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

RUX group

Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil DRUG

calcineurin inhibitor and short course of methotrexate and mycophenolate mofetil

Control group

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The First Hospital of Zhejiang Medical Colleage Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 9, 2021
• Study Start: April 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)