MTX and Steroid as First-line Therapy for aGVHD

NCT04960644 | Completed Phase 3

• 1 other identifier: NFEC-202105-K3-01
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute GVH Disease

Keywords

acute GVHD; MTX; Corticosteroid

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR) for aGVHD 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

  10 days

Secondary Outcomes (9)

• Overall response rate (ORR) for aGVHD treatment at 28 days after treatment

  28 days

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

  42 days

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

  42 days

• cGVHD

  1 years

• Infection and poor graft function

  1 year

Study Arms (2)

MTX and corticosteroid

EXPERIMENTAL

perimental: MTX and corticosteroid Methylprednisolone 1 mg/kg/day was given for 10 days and then gradually reduce the dose according to patient's response MTX (5-6mg/m\^2/day,Maximum dose 10mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR

Drug: MTX

corticosteroid

ACTIVE COMPARATOR

perimental: corticosteroid Methylprednisolone 1 mg/kg/day was given for 10 days and then gradually reduce the dose according to patient's response

Drug: Corticosteroid

Interventions

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

Also known as: Corticosteroid

MTX and 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

corticosteroid

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

Related Publications (1)

• Wang Y, Liu QF, Wu DP, Xu ZL, Han TT, Sun YQ, Huang F, Fan ZP, Xu N, Chen F, Zhao Y, Kong Y, Mo XD, Xu LP, Zhang XH, Liu KY, Huang XJ. Mini-dose methotrexate combined with methylprednisolone for the initial treatment of acute GVHD: a multicentre, randomized trial. BMC Med. 2024 Apr 25;22(1):176. doi: 10.1186/s12916-024-03395-y.

  PMID: 38664766 DERIVED

MeSH Terms

Interventions

Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Xiao-Jun Huang, Dr.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Hematology

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 14, 2021
• Study Start: June 25, 2021
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)