ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04203108

Collaborator

(none)

266

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hematopoietic Stem Cell Transplantation	Drug: ATG Drug: CsA Drug: MTX Drug: MMF	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

266 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Aug 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

the incidence of cGVHD [2 year posttransplantation]
cGVHD was graded as limited or extensive.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A patient age of 18-65 years
MSD transplant recipient
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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong	China

Sponsors and Collaborators

Nanfang Hospital of Southern Medical University

Investigators

Principal Investigator: Qifa Liu, Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qifa Liu, Professor, Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT04203108

Other Study ID Numbers:

ATG in HLA-matched HSCT-2019

First Posted:

Dec 18, 2019

Last Update Posted:

Dec 18, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Qifa Liu, Professor, Nanfang Hospital of Southern Medical University

Hematopoietic Stem Cell Transplantation

antithymocyte globulin

graft-versus-host disease

Study Results

No Results Posted as of Dec 18, 2019