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Recruiting NCT05921305

Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD

Phase III Interventional Acute Graft Versus Host Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MTX, Corticosteroid.
Who it may be relevant to
Registry conditions: Acute Graft Versus Host Disease. Basic parameters: 15 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Trial of Mini-dose Methotrexate Plus Standard-dose Steroid vs Steroids for the Initial Treatment of Acute Graft Versus Host Disease

Overview

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.

Interventions

  • Drug MTX
    MTX (5mg/m\^2/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR
  • Drug Corticosteroid
    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 measures

  • Overall response rate (ORR) for aGVHD treatment after treatment [Time frame: 14 days]
Secondary outcome measures (9)
  • Overall response rate (ORR) for aGVHD treatment at 28 days after treatment [Time frame: 28 days]
  • Overall response rate (ORR) for aGVHD treatment at 42 days after treatment [Time frame: 42 days]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time frame: 42 days]
  • cGVHD [Time frame: 1 years]
  • Infection and poor graft function [Time frame: 1 year]
  • Relapse [Time frame: 1 year]
  • Non-relapse mortality [Time frame: 1 year]
  • Overall survival [Time frame: 1 year]
  • Disease free survival [Time frame: 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Peking University Institute of Hematology, — Beijing
  • Nanfang Hospital, Nanfang Medical University — Guangzhou

Identifiers

NCT: NCT05921305 · GVHD-MTX-Randomized trial

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗