search
Back to results

MTX and Steroid for III-IV aGVHD Treatment

Primary Purpose

Acute Graft Versus Host Disease

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Methotrexate
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Graft Versus Host Disease focused on measuring acute GVHD, MTX, Corticosteroid

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients who are fully informed and sign informed consent by themselves or their guardians;
  2. Patients receiving allogeneic hematopoietic stem cell transplantation;
  3. Patients with acute graft-versus-host disease of grade III-IV were diagnosed after transplantation;
  4. Patients with stable implantation of granulocytes and platelets.

Exclusion Criteria:

  1. Patients who have received more than one transplant;
  2. Patients with overlap syndrome;
  3. Patients within six months after the failure of the first transplantation;
  4. Patients with uncontrollable active infection;
  5. Patients with recurrence of primary malignant hematopathy;
  6. Patients with donor lymphocyte infusion induced graft-versus-host disease after first intervention;
  7. Patients with serious respiratory diseases;
  8. Patients with severe renal insufficiency;
  9. Patients with serious and uncontrolled heart disease;
  10. Patients with severe hepatobiliary diseases unrelated to graft-versus host disease;
  11. Within one week patients who need to use more than 1mg/kg/d methylprednisolone for reasons other than graft-versus-host disease;
  12. patients who have participated in other clinical trials within 1 month;
  13. The researcher judges that there are other factors that are not suitable for participating

Sites / Locations

  • Peking University Institute of Hematology,Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MTX and corticosteroid

Arm Description

Methylprednisolone 2 mg/kg/day MTX (5-10 mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was less than grade II

Outcomes

Primary Outcome Measures

Overall response rate (ORR) for GVHD 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) 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
relapse rate
Relapse rate is defined as the proportion of patients demonstrating a morphological relapse of the original malignant hematological disease
Non-relapse mortality
Non-relapse mortality
Overall survival
Overall survival
Disease free survival
Disease free survival
Failure free survival
Failure free survival
Chronic GVHD
number of participants with chronic GVHD at one year

Full Information

First Posted
June 23, 2021
Last Updated
April 19, 2022
Sponsor
Peking University People's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04958538
Brief Title
MTX and Steroid for III-IV aGVHD Treatment
Official Title
A Single-cohort, Phase II Study of Methotrexate Combined Corticosteroid in Chinese Patients With Grade III-IV Acute Graft vs. Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
January 30, 2023 (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
The aim of the study is to identify the efficacy and safety of methotrexate (MTX) combined corticosteroid treatment for grade III-IV acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Detailed Description
Allo-HSCT is an effective treatment of malignant hematopoietic diseases. However, aGVHD remains a major complication after allo-HSCT and the destruction of recipient tissues by alloantigen-activated T cells is a key event in the development of aGVHD. Corticosteroid is the standard first-line therapy for aGVHD due to their roles in suppressing T cell responses. 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 further ameliorate the activity of T cells and 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
Keywords
acute GVHD, MTX, Corticosteroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MTX and corticosteroid
Arm Type
Experimental
Arm Description
Methylprednisolone 2 mg/kg/day MTX (5-10 mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was less than grade II
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
Corticosteroid
Intervention Description
Methylprednisolone 2 mg/kg/day MTX (5-10 mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was less than grade II
Primary Outcome Measure Information:
Title
Overall response rate (ORR) for GVHD 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) 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
relapse rate
Description
Relapse rate is defined as the proportion of patients demonstrating a morphological relapse of the original malignant hematological disease
Time Frame
1 year
Title
Non-relapse mortality
Description
Non-relapse mortality
Time Frame
1 year
Title
Overall survival
Description
Overall survival
Time Frame
1 year
Title
Disease free survival
Description
Disease free survival
Time Frame
1 year
Title
Failure free survival
Description
Failure free survival
Time Frame
1 year
Title
Chronic GVHD
Description
number of participants with chronic GVHD at one year
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Safety data (side effect)
Description
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.
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 allogeneic hematopoietic stem cell transplantation; Patients with acute graft-versus-host disease of grade III-IV were diagnosed after transplantation; Patients with stable implantation of granulocytes and platelets. Exclusion Criteria: Patients who have received more than one transplant; Patients with overlap syndrome; Patients within six months after the failure of the first transplantation; Patients with uncontrollable active infection; Patients with recurrence of primary malignant hematopathy; Patients with donor lymphocyte infusion induced graft-versus-host disease after first intervention; Patients with serious respiratory diseases; Patients with severe renal insufficiency; Patients with serious and uncontrolled heart disease; Patients with severe hepatobiliary diseases unrelated to graft-versus host disease; Within one week patients who need to use more than 1mg/kg/d methylprednisolone for reasons other than graft-versus-host disease; patients who have participated in other clinical trials within 1 month; The researcher judges that there are other factors that are not suitable for participating
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Wang, Dr.
Phone
86-13552647384
Email
ywyw3172@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-Jun Huang, Dr.
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
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

12. IPD Sharing Statement

Learn more about this trial

MTX and Steroid for III-IV aGVHD Treatment

We'll reach out to this number within 24 hrs