ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04203108

Enrollment

266

Registered

2019-12-18

Start date

2019-09-01

Completion date

2022-12-31

Last updated

2019-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

Hematopoietic Stem Cell Transplantation, antithymocyte globulin, graft-versus-host disease

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.

Interventions

DRUGATG

In ATG group, ATG will be intravenously infused via a central venous catheter in day -1 at a dose of 2.5mg/kg.

DRUGCsA

In both groups, CsA will be intravenously infused from day -9 and the dose was adjusted based on the concentration.

DRUGMTX

In both groups, MTX will be intravenously on days +1(15mg), +3(10mg) and +6(10mg).

DRUGMMF

In both groups, MMF will be administrated at a dose of 1.0g/d.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactRen Lin, MD

lansinglinren@hotmail.com+86-020-62787883

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026