ATG-F VS ATG for the Prevention of GVHD

Comparing ATG-Fresenius vs Thymoglobulin for the Prevention of Graft-versus-host Disease in the Setting of Haplo-identical Hematopoietic Stem Cell Transplantation

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03631563

Enrollment

120

Registered

2018-08-15

Start date

2013-03-01

Completion date

2020-12-01

Last updated

2018-08-15

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

Conditions

GVHD in the Setting of Haplo-HSCT

Brief summary

Anti-thymocyte globulin (ATG) preparative regimen in the setting of haploidentical stem cell transplantation (haplo-HSCT) is vital for inducing immune tolerance.The study aims to compare the efficacy and safety of ATG-F vs ATG, incorporated into the preparative regimens for haplo-identical transplants.

Interventions

DRUGImmunosuppressive Agent

ATG-Fresenius versus ATG

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 65 Years

Inclusion criteria

* Signed written informed consent * Aged \<65 years * Patients undergoing Haplo-identical hematopoietic stem cell transplantation. * Cardiac: Left ventricular ejection fraction ≥ 50% * Adequate renal and hepatic function * Performance status: Karnofsky ≥ 70%

Exclusion criteria

* Pregnant or lactating females. * Any co-morbidity precluding the administration of ATG or ATG-F.

Design outcomes

Primary

Measure	Time frame
incidence of GVHD	1 year

Secondary

Measure	Time frame
leukemia-free survival	1 year
treatment-related mortality	1 year

Countries

China

Contacts

Primary ContactTing Yang, Prof.M.D.Ph.D

yang.hopeting@gmail.com86-13950210357

Outcome results

None listed

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