NCT04677868

Brief Summary

The aim of the study is to identify the efficacy and safety of methotrexate (MTX) combined corticosteroid treatment for 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 Dec 2020

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

December 23, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

December 13, 2020

Last Update Submit

September 14, 2021

Conditions

Acute GVH Disease

Keywords

acute GVHDMTXCorticosteroid

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (ORR) for GVHD treatment at 7 days 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.

    7 days

Secondary Outcomes (7)

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

    28 days

  • Relapse

    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

    1 year

Study Arms (1)

MTX and corticosteroid

EXPERIMENTAL

Methylprednisolone 1 mg/kg/day MTX (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 1 mg/kg/day MTX (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

Age16 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 II-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 DLI or 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, 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

Xiao-Dong Mo, Dr

CONTACT

86-10-88326001mxd453@163.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
Director

Study Record Dates

First Submitted

December 13, 2020

First Posted

December 21, 2020

Study Start

December 23, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2022

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

CN(1)