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Completed

NCT Number: NCT04960644

MTX and Steroid as First-line Therapy for aGVHD

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

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Key information

Conditions

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital

Beijing, 100044, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 II-IV were diagnosed after transplantation;
  • Patients with stable implantation of granulocytes and platelets.
  • ECOG score ≤3

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

Treatment and study plan

MTX

Drug

MTX (5-10 mg/day,Dmax 10mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR

Other names: Corticosteroid

Corticosteroid

Drug

corticosteroid Methylprednisolone 1 mg/kg/day was given for 10 days and then the dosage was gradually reduced according to patient's response

Primary outcomes

  1. Overall response rate (ORR) for aGVHD treatment after treatment

    Time frame: 10 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 outcomes

  1. Overall response rate (ORR) for aGVHD treatment 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. Overall response rate (ORR) for aGVHD treatment at 42 days after treatment

    Time frame: 42 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

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 42 days

    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.

  4. cGVHD

    Time frame: 1 years

    The cumulative incidence of chronic GVHD

  5. Infection and poor graft function

    Time frame: 1 year

    The cumulative incidence of severe infection and poor graft function

  6. Relapse

    Time frame: 1 year

    The cumulative incidence of relapse

  7. Non-relapse mortality

    Time frame: 1 year

    The cumulative incidence of non-relapse mortality

  8. Overall survival

    Time frame: 1 year

    The cumulative incidence of overall survival

  9. Disease free survival

    Time frame: 1 year

    The cumulative incidence of disease free survival

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

A Multi-cohort, Phase Ⅲ Study of Methotrexate Combined Corticosteroid as First-line Therapy in Chinese Patients With Acute Graft vs. Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 14, 2021
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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