Allogeneic hematopoietic stem cell transplantation from a two HLA-haplotype-mismatched family donor for post-transplant relapse/rejection: A prospective phase II study with statistical validation for survival benefit

2-HLA-haplotype-mismatched hematopietic stem cell transplantation - 2-HLA-haplotype-mismatched HSCT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000043973

Enrollment

Registered

2021-05-01

Start date

2021-06-01

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

hematologic malignancies relapsing or with rejection after allogeneic hematopoietic stem cell transplantation

Interventions

Allogeneic hematopoietic stem cell transplantation from a two HLA-haplotype-mismatched family donor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) age 15-65 years old 2) relapse or rejection case after allogeneic HSCT 3) hematologic malignancies mainly acute type leukemia 4) 2-HLA-haplotype-mismatach between patient and donor

Exclusion criteria

Exclusion criteria: 1) serum Cre >2.0 mg/dl 2) serum T-Bil >2.0 mg/dl 3) selum AST and/or ALT >200 U/L 4) EF <45% 5) SpO2 <95% (room air) 6) PS (ECOG score) 3-4

Design outcomes

Primary

Measure	Time frame
overall survival at 2 years	—

Secondary

Measure	Time frame
Safety 1) rate of engraftment at day 35 2) acute GVHD within day 100 3) complications (infections, TMA, etc) 4) other AE 5) non-relapse mortality efficacy 6) relapse rate 7) disease-free survival	—

Countries

Japan

Contacts

Public ContactKazuhiro Ikegame

Hyogo College of Medicine Hematology

haplo@hyo-med.ac.jp+81798456886

Outcome results

None listed

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