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MTX and Steroid for aGVHD Treatment

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ClinicalTrials.gov Identifier: NCT04677868
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Xiao-Jun Huang, Peking University People's Hospital

Study Description
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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
Acute GVH Disease Drug: Methotrexate 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 23, 2020
Actual Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arms and Interventions
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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 Name: Corticosteroid


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate (ORR) for GVHD treatment at 7 days after treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year ]
    Relapse

  3. Non-relapse mortality [ Time Frame: 1 year ]
    Non-relapse mortality

  4. Overall survival [ Time Frame: 1 year ]
    Overall survival

  5. Disease free survival [ Time Frame: 1 year ]
    Disease free survival

  6. Failure free survival [ Time Frame: 1 year ]
    Failure free survival

  7. Chronic GVHD [ Time Frame: 1 year ]
    Chronic GVHD


Other Outcome Measures:
  1. Safety data [ Time Frame: 1 year ]
    Safety data


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04677868


Contacts
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Contact: Xiao-Dong Mo, Dr 86-10-88326001 mxd453@163.com

Locations
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China, Beijing
Peking University Institute of Hematology,Beijing Recruiting
Beijing, Beijing, China, 100044
Contact: Xiao-Dong Mo       mxd453@163.com   
Principal Investigator: Xiao-Jun Huang, MD         
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Xiao-Jun Huang, Dr Peking University People's Hospital
More Information
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Responsible Party: Xiao-Jun Huang, Director, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT04677868    
Other Study ID Numbers: MCSAG1
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiao-Jun Huang, Peking University People's Hospital:
acute GVHD
MTX
Corticosteroid
Additional relevant MeSH terms:
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Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors