ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis

December 16, 2019 updated by: Qifa Liu, Nanfang Hospital of Southern Medical University

ATG Used in Allogeneic Hematopoietic Stem Cell Transplantation From HLA-matched Sibling Donor as GVHD Prophylaxis

The protocols including ciclosporin A （CsA）+methotrexate (MTX) +mycophenolate Mofetil(MMF) have been widely used for graft-versus-host disease (GVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation from HLA-matched sibling donor (MSD). Nevertheless, severe chronic graft-versus-host disease (cGVHD) remains an obstacle for MSD HSCT. A growing body of studies have suggested antithymocyte globulin (ATG) could reduce the incidence of cGVHD. This study is aim to evaluate the efficacy of a protocol that includes CsA, MTX, MMF and ATG in recipients of MSD HSCT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

266

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Nanfang Hospital of Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. A patient age of 18-65 years
  2. MSD transplant recipient
  3. Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

  1. Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
  2. Patients with any conditions not suitable for the trial (investigators' decision)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ATG group
ATG group refers to treatment with a protocol including low-dose ATG, CsA, short-term MTX and MMF as GVHD prophylaxis.
Drug: ATG
In ATG group, ATG will be intravenously infused via a central venous catheter in day -1 at a dose of 2.5mg/kg.
Drug: CsA
In both groups, CsA will be intravenously infused from day -9 and the dose was adjusted based on the concentration.
Drug: MTX
In both groups, MTX will be intravenously on days +1(15mg), +3(10mg) and +6(10mg).
Drug: MMF
In both groups, MMF will be administrated at a dose of 1.0g/d.
Active Comparator: non-ATG group
Non-ATG group refers to treatment with a protocol including CsA, short-term MTX and MMF as GVHD prophylaxis.
Drug: CsA
In both groups, CsA will be intravenously infused from day -9 and the dose was adjusted based on the concentration.
Drug: MTX
In both groups, MTX will be intravenously on days +1(15mg), +3(10mg) and +6(10mg).
Drug: MMF
In both groups, MMF will be administrated at a dose of 1.0g/d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of cGVHD
Time Frame: 2 year posttransplantation
cGVHD was graded as limited or extensive.
2 year posttransplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 2 year posttransplantation
2 year posttransplantation
disease-free survival
Time Frame: 2 year posttransplantation
2 year posttransplantation
the incidence of aGVHD
Time Frame: 100 days 1 year posttransplantation
aGVHD was defined according to the 1994 Consensus Conference on Acute GVHD Grading and graded from I to IV.
100 days 1 year posttransplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (Actual)

December 18, 2019

Study Record Updates

Last Update Posted (Actual)

December 18, 2019

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ATG in HLA-matched HSCT-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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