ATG-F VS ATG for the Prevention of GVHD

Fujian Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: GVHD in the Setting of Haplo-HSCT

Treatments: Drug: Immunosuppressive Agent

Study type: Interventional

Funder types: Other

Identifiers

NCT03631563

ATG-F VS ATG-01

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Arm 1

Experimental group

Description:

ATG-F treated

Treatment:

Drug: Immunosuppressive Agent

Arm 2

Active Comparator group

Description:

ATG treated

Treatment:

Drug: Immunosuppressive Agent