Back to resultsMini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD
Primary Purpose
Acute Graft Versus Host Disease
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
MTX
Corticosteroid
Sponsored by
About this trial
This is an interventional treatment trial for Acute Graft Versus Host Disease
Eligibility Criteria
Inclusion Criteria: Patients who are fully informed and sign informed consent by themselves or their guardians; Patients receiving first allogeneic hematopoietic stem cell transplantation; Patients with acute graft-versus-host disease of grade II-IV were diagnosed after transplantation; KPS>60, Estimated survival >3 months; No serious organ damage: ANC in peripheral blood is greater than 0.5×109/l Creatinine < 1.5mg/dl Cardiac ejection index > 55% Exclusion Criteria: Patients with severe brain, heart, kidney or liver dysfunction unrelated to graft-versus host disease; Patients with uncontrollable active infection; Patients with recurrence of primary malignant hematopathy; Expected survival is less than 3 months Patients who have histories of severe allergic reactions Pregnant or lactating women The researcher judges that there are other factors that are not suitable for participating Patients who received donor lymphocyte infusion
Sites / Locations
- Peking University Institute of Hematology,Recruiting
- Nanfang Hospital, Nanfang Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MTX and corticosteroid
Corticosteroid
Arm Description
Methylprednisolone 2 mg/kg/day was given for 3 days, and for responding patients, the dose of prednisone must be at least 0.25mg/kg/day prednisone (or 0.2mg/kg/day methylprednisolone). MTX (5mg/m^2/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR.
Methylprednisolone 2 mg/kg/day was given for 3 days, and for responding patients, the dose of prednisone must be at least 0.25mg/kg/day prednisone (or 0.2mg/kg/day methylprednisolone).
Outcomes
Primary Outcome Measures
Overall response rate (ORR) for aGVHD treatment after treatment
Overall response rate is defined as the proportion of patients demonstrating a complete response or partial response without requirement for additional systemic therapies for an earlier progression, mixed response or non-response
Secondary Outcome Measures
Overall response rate (ORR) for aGVHD treatment at 28 days after treatment
Overall response rate is defined as the proportion of patients demonstrating a complete response or partial response without requirement for additional systemic therapies for an earlier progression, mixed response or non-response
Overall response rate (ORR) for aGVHD treatment at 42 days after treatment
Overall response rate is defined as the proportion of patients demonstrating a complete response or partial response without requirement for additional systemic therapies for an earlier progression, mixed response or non-response
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Data collection including questionnaires at individual and group visits and physician interviews at individual visits will be used to assess participants for treatment-related adverse events.
cGVHD
The cumulative incidence of chronic GVHD
Infection and poor graft function
The cumulative incidence of severe infection and poor graft function
Relapse
The cumulative incidence of relapse
Non-relapse mortality
The cumulative incidence of non-relapse mortality
Overall survival
The cumulative incidence of overall survival
Disease free survival
The cumulative incidence of disease free survival
Full Information
NCT ID
NCT05921305
First Posted
June 19, 2023
Last Updated
October 7, 2023
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05921305
Brief Title
Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD
Official Title
Randomized Trial of Mini-dose Methotrexate Plus Standard-dose Steroid vs Steroids for the Initial Treatment of Acute Graft Versus Host Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This trial is a randomized (1:1) phase III open label study of frontline mini-MTX plus methylprednisolone 2mg/kg/day compared to methylprednisolone 2mg/kg in allogeneic stem cell transplant recipients with grade 2-4 aGVHD.
Detailed Description
Allo-HSCT is an effective treatment of malignant hematopoietic diseases. However, aGVHD remains a major complication after allo-HSCT. Corticosteroid is the standard first-line therapy for aGVHD. However, the response rate of corticosteroid was approximate 50%, and the clinical outcomes of patients with corticosteroid refractory GVHD were poor. Thus far, no combination therapy had been prove to be superior to corticosteroid alone as initial therapy for aGVHD. The study hypothesis: MTX combined corticosteroid treatment could help to control aGVHD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Graft Versus Host Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MTX and corticosteroid
Arm Type
Experimental
Arm Description
Methylprednisolone 2 mg/kg/day was given for 3 days, and for responding patients, the dose of prednisone must be at least 0.25mg/kg/day prednisone (or 0.2mg/kg/day methylprednisolone). MTX (5mg/m^2/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR.
Arm Title
Corticosteroid
Arm Type
Active Comparator
Arm Description
Methylprednisolone 2 mg/kg/day was given for 3 days, and for responding patients, the dose of prednisone must be at least 0.25mg/kg/day prednisone (or 0.2mg/kg/day methylprednisolone).
Intervention Type
Drug
Intervention Name(s)
MTX
Intervention Description
MTX (5mg/m^2/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Intervention Description
Corticosteroid Methylprednisolone 2 mg/kg/day was given for 3 days, and for responding patients, the dose of prednisone must be at least 0.25mg/kg/day prednisone (or 0.2mg/kg/day methylprednisolone).
Primary Outcome Measure Information:
Title
Overall response rate (ORR) for aGVHD treatment after treatment
Description
Overall response rate is defined as the proportion of patients demonstrating a complete response or partial response without requirement for additional systemic therapies for an earlier progression, mixed response or non-response
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Overall response rate (ORR) for aGVHD treatment at 28 days after treatment
Description
Overall response rate is defined as the proportion of patients demonstrating a complete response or partial response without requirement for additional systemic therapies for an earlier progression, mixed response or non-response
Time Frame
28 days
Title
Overall response rate (ORR) for aGVHD treatment at 42 days after treatment
Description
Overall response rate is defined as the proportion of patients demonstrating a complete response or partial response without requirement for additional systemic therapies for an earlier progression, mixed response or non-response
Time Frame
42 days
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Data collection including questionnaires at individual and group visits and physician interviews at individual visits will be used to assess participants for treatment-related adverse events.
Time Frame
42 days
Title
cGVHD
Description
The cumulative incidence of chronic GVHD
Time Frame
1 years
Title
Infection and poor graft function
Description
The cumulative incidence of severe infection and poor graft function
Time Frame
1 year
Title
Relapse
Description
The cumulative incidence of relapse
Time Frame
1 year
Title
Non-relapse mortality
Description
The cumulative incidence of non-relapse mortality
Time Frame
1 year
Title
Overall survival
Description
The cumulative incidence of overall survival
Time Frame
1 year
Title
Disease free survival
Description
The cumulative incidence of disease free survival
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are fully informed and sign informed consent by themselves or their guardians;
Patients receiving first allogeneic hematopoietic stem cell transplantation;
Patients with acute graft-versus-host disease of grade II-IV were diagnosed after transplantation;
KPS>60, Estimated survival >3 months;
No serious organ damage:
ANC in peripheral blood is greater than 0.5×109/l
Creatinine < 1.5mg/dl
Cardiac ejection index > 55%
Exclusion Criteria:
Patients with severe brain, heart, kidney or liver dysfunction unrelated to graft-versus host disease;
Patients with uncontrollable active infection;
Patients with recurrence of primary malignant hematopathy;
Expected survival is less than 3 months
Patients who have histories of severe allergic reactions
Pregnant or lactating women
The researcher judges that there are other factors that are not suitable for participating
Patients who received donor lymphocyte infusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Wang, M.D.
Phone
86-13552647384
Email
ywyw3172@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-Jun Huang, M.D.
Facility Information:
Facility Name
Peking University Institute of Hematology,
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Wang, Dr.
Phone
13552647384
Email
ywyw3172@sina.com
Facility Name
Nanfang Hospital, Nanfang Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qifa liu, M.D.
Email
liuqifa628@163.com
First Name & Middle Initial & Last Name & Degree
qifa liu, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD
We'll reach out to this number within 24 hrs