Dose Study of Antithymocyteglobulin in Haploidentical Allogeneic Stem Cell Transplantation

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Hematopoietic Stem Cell Transplantation

Treatments: Drug: ATG

Study type: Interventional

Funder types: Other

Identifiers

NCT02643589

NFEC-201304-K1(02)

Details and patient eligibility

About

The purpose of this study is to compare the incidences of GVHD in haploidentical hematopoietic stem cell transplant recipients receiving different dose of antithymocyte globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. The investigators' first objective was to investigate the optimal dose of ATG for aGVHD.

Full description

Graft-versus-host diseases (GVHD) remains a major cause of morbility and mortality after allogeneic hematopoietic stem cell transplantation (HSCT) with grafts from an HLA-mismatched family donor. Antithymocyteglobulin (ATG) has been widely used to prevent acute GVHD (aGVHD) in haploidentical HSCT. Notwithstanding, immunosuppressive effect of ATG, which may also increase the risk of opportunistic infections, necessitates the use of the lowest possible dose. Till now, the optimal dose of ATG is not known. Here, the investigators compared the outcome of patients receiving haploidentical HSCT treated with two different doses of ATG.

Enrollment: 200 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Haploidentical hematopoietic stem cell transplant recipient
• 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

• Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
• Patients with any conditions not suitable for the trial (investigators' decision)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

ATG 7.5mg/kg

Experimental group

Description:

ATG 7.5mg/kg group refers to treatment with ATG in the total dose of 7.5mg/kg.

Treatment:

Drug: ATG

ATG 10mg/kg

Active Comparator group

Description:

ATG 10mg/kg group refers to treatment with ATG in the total dose of 10mg/kg.

Treatment:

Drug: ATG