NCT05921305

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P25-P50 for phase_3

Timeline
4mo left

Started Aug 2023

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Aug 2023Sep 2026

First Submitted

Initial submission to the registry

June 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 3, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

2.9 years

First QC Date

June 19, 2023

Last Update Submit

May 28, 2025

Conditions

Acute Graft Versus Host Disease

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

    14 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

  • +4 more secondary outcomes

Study Arms (2)

MTX and corticosteroid

EXPERIMENTAL

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

Drug: MTX

Corticosteroid

ACTIVE COMPARATOR

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).

Drug: Corticosteroid

Interventions

MTXDRUG

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

MTX and corticosteroid
CorticosteroidDRUG

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).

Corticosteroid

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (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 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 0.5Ă—109/l
  • Creatinine \< 1.5mg/dl
  • Cardiac ejection index \> 55%

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
  • Patients who received donor lymphocyte infusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University Institute of Hematology,

Beijing, Beijing Municipality, 100044, China

RECRUITING

Nanfang Hospital, Nanfang Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Interventions

Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Yu Wang, M.D.

CONTACT

86-13552647384ywyw3172@sina.com

Xiao-Jun Huang, M.D.

CONTACT

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
director, hematology department,Peking University People's Hospital

Study Record Dates

First Submitted

June 19, 2023

First Posted

June 27, 2023

Study Start

August 3, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

June 3, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)