NCT04958538

Brief Summary

The aim of the study is to identify the efficacy and safety of methotrexate (MTX) combined corticosteroid treatment for grade III-IV acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

1.7 years

First QC Date

June 23, 2021

Last Update Submit

April 19, 2022

Conditions

Acute Graft Versus Host Disease

Keywords

acute GVHDMTXCorticosteroid

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (ORR) for GVHD 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 (7)

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

    28 days

  • relapse rate

    1 year

  • Non-relapse mortality

    1 year

  • Overall survival

    1 year

  • Disease free survival

    1 year

  • +2 more secondary outcomes

Other Outcomes (1)

  • Safety data (side effect)

    1 year

Study Arms (1)

MTX and corticosteroid

EXPERIMENTAL

Methylprednisolone 2 mg/kg/day MTX (5-10 mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was less than grade II

Drug: Methotrexate

Interventions

MethotrexateDRUG

Methylprednisolone 2 mg/kg/day MTX (5-10 mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was less than grade II

Also known as: Corticosteroid
MTX and 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 allogeneic hematopoietic stem cell transplantation;
  • Patients with acute graft-versus-host disease of grade III-IV were diagnosed after transplantation;
  • Patients with stable implantation of granulocytes and platelets.

You may not qualify if:

  • Patients who have received more than one transplant;
  • Patients with overlap syndrome;
  • Patients within six months after the failure of the first transplantation;
  • Patients with uncontrollable active infection;
  • Patients with recurrence of primary malignant hematopathy;
  • Patients with donor lymphocyte infusion induced graft-versus-host disease after first intervention;
  • Patients with serious respiratory diseases;
  • Patients with severe renal insufficiency;
  • Patients with serious and uncontrolled heart disease;
  • Patients with severe hepatobiliary diseases unrelated to graft-versus host disease;
  • Within one week patients who need to use more than 1mg/kg/d methylprednisolone for reasons other than graft-versus-host disease;
  • patients who have participated in other clinical trials within 1 month;
  • The researcher judges that there are other factors that are not suitable for participating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Institute of Hematology,

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Interventions

MethotrexateAdrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Xiao-Jun Huang, Dr.

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Wang, Dr.

CONTACT

86-13552647384ywyw3172@sina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Hematology

Study Record Dates

First Submitted

June 23, 2021

First Posted

July 12, 2021

Study Start

April 21, 2021

Primary Completion

December 31, 2022

Study Completion

January 30, 2023

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations

CN(1)