Hematopoietic stem cell transplantation from HLA fully mismatched family members for post-transplant relapse/rejection (phase I/II trial)

Hematopoietic stem cell transplantation from HLA fully mismatched family members for post-transplant relapse/rejection (phase I/II trial) - HLA fully mismatched hematopietic stem cell transplantation

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023548

Enrollment

Registered

2016-08-09

Start date

2016-08-09

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 relapesd/rejected after allogeneic stem cell transplantation

Interventions

The basic structure of the preconditioning regimen consists of fludarabine (FLU) at 30 mg/m2/day for 6 days (days -9 and -4), melphalan (MEL) at 70 mg/ m2/day for 2 days (days -3 and -2), and rabbit a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with hematologic malignancies relapsed or rejected after allogeneic stem cell transplantation who fulfill the following (patient and donor), [patient] 1) Written informed consent 2) no expectancy of cure with standard therapies including DLI [donor] 1) healthy spouse who desires to become the donor 2) no available or suitable donor in unrelate bank, cord blood bank, haploidentical relatives (confirmed by the conference)

Exclusion criteria

Exclusion criteria: 1) Cre > 2.0 mg/dl 2) EF < 40% 3) T-Bil > 2.0 mg/dl 4) AST and/or ALT > 200 U/L 5) SpO2 < 90% (room air) 6) PS (ECOG score) 3-4 Patients with data due to original disease are not excluded.

Design outcomes

Primary

Measure	Time frame
Rate of donor cell engraftment (defined as Neutrophil >500/microL with >90% of donor origin) on day 35	—

Secondary

Measure	Time frame
a) Incidence and severity of chronic GVHD b) transplantion-associated complications, including TMA c) survival rate d) relapse rate e) other adverse effects (CTCAE) within three months	—

Countries

Japan

Contacts

Public ContactKazuhiro Ikegame

Hyogo College of Medicine Division of Hematology, Department of Internal Medicine

kame@hyo-med.ac.jp+81-798-45-6886

Outcome results

None listed

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