ATG-F VS ATG for the Prevention of GVHD

Fujian Medical University120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

GVHD in the Setting of Haplo-HSCT

Interventions

Immunosuppressive AgentDRUG

ATG-Fresenius versus ATG

Eligibility

Sex: ALLMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

Outcomes

Primary Outcomes

incidence of GVHD

Time frame: 1 year

Secondary Outcomes

leukemia-free survival

Time frame: 1 year

treatment-related mortality

Time frame: 1 year

Central Contacts

Ting Yang, Prof.M.D.Ph.D

CONTACT

86-13950210357 yang.hopeting@gmail.com

Data from ClinicalTrials.gov

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