ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 4

Conditions: Hematopoietic Stem Cell Transplantation

Treatments: Drug: MMF; Drug: CsA; Drug: ATG; Drug: MTX

Study type: Interventional

Funder types: Other

Identifiers

NCT04203108

ATG in HLA-matched HSCT-2019

Details and patient eligibility

About

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.

Enrollment: 266 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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266 participants in 2 patient groups

ATG group

Experimental group

Description:

ATG group refers to treatment with a protocol including low-dose ATG, CsA, short-term MTX and MMF as GVHD prophylaxis.

Treatment:

Drug: CsA

Drug: ATG

Drug: MMF

Drug: MTX

non-ATG group

Active Comparator group

Description:

Non-ATG group refers to treatment with a protocol including CsA, short-term MTX and MMF as GVHD prophylaxis.

Treatment:

Drug: CsA

Drug: MMF

Drug: MTX