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.

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. - HSCT from a related donor with HLA-1 Ag mismatch using ATG

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011192

Enrollment

Registered

2013-07-16

Start date

2013-08-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

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

Interventions

Prophylaxis against GVHD is performed with tacrolimus, methotrexate, and thymoglobulin (anti-thymocyte globulin). Tacrolimus is started on day -1 at a dose of 0.03 mg/kg per day by continuous infusio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who have one of the following disease statuses (a) AML:any stages with <=50% of blasts in BM and PB (b) ALL:any stages with <=50% of blasts in BM and PB (c) ATL:any stages with <=50% of malignant cells in BM and PB (d) CML:stages with either >=CP2, AP, BP, or failure to 2 types of TKIs (imatinib, dasatinib, nilotinib), with <=50% of blasts in BM and PB (e) MDS:IPSS, intermediate-II or high; WPSS, intermediate-II or high; relapse after remission (f) NHL:patients who have one of the following statuses (1) low-grade lymphoma:chemo-refractory, relapse after autologous SCT (2) intermediate-grade lymphoma:PR,>=CR2 (3) high-grade lymphoma:PR, CR (g) Hodgkin lymphoma:PR, >=CR2 2. Patients who are 16 to 65 years old 3. Patients who do not have an available HLA-A, -B, -DR matched related donor 4. Patients who do not have an HLA-A, -B, -C, -DRB1 8/8 allele matched unrelated donor candidate, or patients whose disease status preclude time-consuming donor coordination. 5. Patients who have a donor with an HLA-1 Ag mismatch in the GVH direction 6. Donors who are 16 to 65 years old 7. Patients with ECOG performance status of 0, 1, or 2 8. Patients whose major organ functions (heart, lung, liver, kidney) are preserved and who meet all of the following criteria (a) Ejection fraction>=40% (b) SaO2>=94% on room air or SpO2>=94% on room air (c) Pulmonary function test: %VC>=70%, FEV1.0%>=70% (d) Serum total bilirubin <=2.0 mg/dl and serum AST<=5 x ULN (e) Ccr >=30ml/min

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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))	—

Countries

Japan

Contacts

Public ContactJunya Kanda

Kyoto University Hospital Department of Hematology

jkanda16@kuhp.kyoto-u.ac.jp075-751-3153

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026