Hematopoietic stem cell transplantation from a related donor with HLA-1 Ag mismatch in the graft-versus-host direction using anti-thymocyte globulin as a GVHD prophylaxis: multicenter phase II trial.

Phase 2

• Conditions: Acute myeloid leukemia Acute lymphoblastic leukemia Adult T cell leukemia Chronic myelogenous leukemia Myelodysplastic syndrome Non-Hodgkin lymphoma Hodgkin lymphoma

• Registration Number: JPRN-UMIN000011192
• Lead Sponsor: HLA Working Group, the Japan Society for Hematopietic Cell Tranplantation. Research Grant for Allergic Disease and Immunology (H23-009) from the Japanese Ministry of Health, Labor, and Welfare.

Brief Summary

39 patients were eligible for the analysis. The 1-year GRFS was 47%. The 3-year OS was 57%. Age of less than 50 years was associated with better OS. OS in patients with high/very high refined disease risk indexes (rDRIs) was comparable to that in those with low/intermediate rDRIs. The 100-day cumulative incidences of grades II-IV and III-IV acute GVHD were 45% and 18%, respectively. Three-year cumulative incidences of moderate to severe or severe chronic GVHD were 13% and 3%, respectively.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-16
• Study Completion: 2018-06-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients with positive donor-specific HLA antibodies 2. Patients with HBs antibody positive 3. Patients with HIV antibody positive 4. Patients with serious mental disorder who are likely unable to participate in the study 5. Patients who are pregnant, nursing, or possibly pregnant 6. Patients with coexistence of malignancy 7. Patients with poorly controlled active infection 8. Patients who are allergic to ATG 9. Patients who have a history of receiving allogeneic stem cell transplantation once or more or a history of receiving autologous stem cell transplantation twice or more

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success rate at 1 year after transplantation. (Success is defined as the situation without the following events within 1 year after transplantation. 1. Death 2. Relapse 3. Grades 3-4 acute GVHD 4. Severe chronic GVHD (NIH criteria))