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
Primary Purpose
Graft Versus Host Disease
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ruxolitinib+Calcineurin +Methotrexate
Calcineurin +Methotrexate+Mycophenolate mofetil
Sponsored by
About this trial
This is an interventional prevention trial for Graft Versus Host Disease focused on measuring Graft Versus Host Disease, ruxolitinib, HLA-haploidentical hematopoietic stem cell transplantation
Eligibility Criteria
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.
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:
- 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.
Sites / Locations
- The First Hospital of Zhejiang Medical Colleage Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RUX group
Control group
Arm Description
Outcomes
Primary Outcome Measures
100-day cumulative II-IV aGVHD incidence after HSCT
100-day cumulative II-IV aGVHD incidence after HSCT
Secondary Outcome Measures
cumulative cGVHD incidence
cGVHD incidence after HSCT
overall survival
overall survival after HSCT
adverse effects
drug related adverse effects
cumulative incidence of relapse after HSCT
cumulative incidence of relapse after HSCT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04838704
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease
Keywords
Graft Versus Host Disease, ruxolitinib, HLA-haploidentical hematopoietic stem cell transplantation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RUX group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib+Calcineurin +Methotrexate
Intervention Description
low-dose ruxolitinib combine with calcineurin and short course of methotrexate.
Intervention Type
Drug
Intervention Name(s)
Calcineurin +Methotrexate+Mycophenolate mofetil
Intervention Description
calcineurin and short course of methotrexate and mycophenolate mofetil
Primary Outcome Measure Information:
Title
100-day cumulative II-IV aGVHD incidence after HSCT
Description
100-day cumulative II-IV aGVHD incidence after HSCT
Time Frame
100-day after HSCT through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
cumulative cGVHD incidence
Description
cGVHD incidence after HSCT
Time Frame
Time after HSCT through study completion, an average of 1 year
Title
overall survival
Description
overall survival after HSCT
Time Frame
Time after HSCT through study completion, an average of 1 year
Title
adverse effects
Description
drug related adverse effects
Time Frame
Time after intervention through study completion, an average of 1 year
Title
cumulative incidence of relapse after HSCT
Description
cumulative incidence of relapse after HSCT
Time Frame
Time after HSCT through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanmin Zhao, PhD
Phone
+8615858199217
Email
zjzhaoyanmin@163.com
Facility Information:
Facility Name
The First Hospital of Zhejiang Medical Colleage Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanmin Zhao, PhD
Phone
+8615858199217
Email
zjzhaoyanmin@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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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