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MTX and Steroid for aGVHD Treatment

Sponsor
Peking University People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04677868
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
17.2
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to identify the efficacy and safety of methotrexate (MTX) combined corticosteroid treatment for acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-cohort, Phase II Study of Methotrexate Combined Corticosteroid in Chinese Patients With Acute Graft vs. Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Actual Study Start Date :
Dec 23, 2020
Actual Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: MTX and corticosteroid

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

Drug: Methotrexate
Methylprednisolone 1 mg/kg/day MTX (10 mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was less than grade II;
Other Names:
  • Corticosteroid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall response rate (ORR) for GVHD treatment at 7 days after treatment [7 days]

      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

    1. Overall response rate (ORR) at 28 days after treatment [28 days]

      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.

    2. Relapse [1 year]

      Relapse

    3. Non-relapse mortality [1 year]

      Non-relapse mortality

    4. Overall survival [1 year]

      Overall survival

    5. Disease free survival [1 year]

      Disease free survival

    6. Failure free survival [1 year]

      Failure free survival

    7. Chronic GVHD [1 year]

      Chronic GVHD

    Other Outcome Measures

    1. Safety data [1 year]

      Safety data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 II-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 DLI or 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Institute of Hematology,Beijing Beijing Beijing China 100044

    Sponsors and Collaborators

    • Peking University People's Hospital

    Investigators

    • Principal Investigator: Xiao-Jun Huang, Dr, Peking University People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiao-Jun Huang, Director, Peking University People's Hospital
    ClinicalTrials.gov Identifier:
    NCT04677868
    Other Study ID Numbers:
    • MCSAG1
    First Posted:
    Dec 21, 2020
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xiao-Jun Huang, Director, Peking University People's Hospital
    acute GVHD
    MTX
    Corticosteroid
    Additional relevant MeSH terms:
    Methotrexate

    Study Results

    No Results Posted as of Sep 16, 2021