ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04203108
• Other study ID #: ATG in HLA-matched HSCT-2019
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2019
• Source: Nanfang Hospital of Southern Medical University
• Contact: Ren Lin, MD
• Phone: +86-020-62787883
• Email: lansinglinren[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplantation

Intervention

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.
• CsA
In both groups, CsA will be intravenously infused from day -9 and the dose was adjusted based on the concentration.
• MTX
In both groups, MTX will be intravenously on days +1(15mg), +3(10mg) and +6(10mg).
• MMF
In both groups, MMF will be administrated at a dose of 1.0g/d.

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of cGVHD	cGVHD was graded as limited or extensive.	2 year posttransplantation
Secondary	overall survival		2 year posttransplantation
Secondary	disease-free survival		2 year posttransplantation
Secondary	the incidence of aGVHD	aGVHD was defined according to the 1994 Consensus Conference on Acute GVHD Grading and graded from I to IV.	100 days 1 year posttransplantation