Spousal hematopoietic cell transplantation

Spousal hematopoietic cell transplantation for post-transplant relapse/rejection: phase I/II study - Spousal hematopoietic cell transplantation for post-transplant relapse/rejection

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000057996

Enrollment

Registered

2025-05-29

Start date

2025-06-01

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

post-transplant relapse/rejection of hematologic malignancies

Interventions

hematopoietic cell transplantation from sousal donor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who underwent spousal hematopoietic stem cell transplantation from the date of study approval up to March 31, 2030.

Exclusion criteria

Exclusion criteria: 1) Serum creatine > 2.0 mg/dL 2) Serum total bilirubin > 2.0 mg/dL 3) Serum AST and/or ALT > 200 U/L 4) Ejection fraction < 45% on echocardiography 5) SpO2 <95% on room air 6) Performance status (ECOG score) of 3-4 However, cases in which these values are elevated due to the underlying disease and are expected to improve with treatment may not necessarily be excluded.

Design outcomes

Primary

Measure	Time frame
Engraftment rate at day 30 after transplantation	—

Secondary

Measure	Time frame
Safety Acute GVHD within 100 days post-transplantation. Complications such as infections and thrombotic microangiopathy (TMA). Other adverse events, evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE). Non-relapse mortality. Efficacy 5) One-year overall survival rate (the observation period ends one year after transplantation for the last enrolled patient). 6) Relapse rate. 7) Disease-free survival rate.	—

Measure

Time frame

Safety Acute GVHD within 100 days post-transplantation. Complications such as infections and thrombotic microangiopathy (TMA). Other adverse events, evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE). Non-relapse mortality. Efficacy 5) One-year overall survival rate (the observation period ends one year after transplantation for the last enrolled patient). 6) Relapse rate. 7) Disease-free survival rate.

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Countries

Japan

Contacts

Public ContactKazuhiro Ikegame

Aichi Medical University Hematopoietic cell transplantation center

kame@aichi-med-u.ac.jp+81-561-63-2086

Outcome results

None listed

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