Hematopietic stem cell transplantation from HLA 2-3 antigen-mismatched family donor using reduced intensity conditioning

Hematopietic stem cell transplantation from HLA 2-3 antigen-mismatched family donor using reduced intensity conditioning - haplo-mini

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023784

Enrollment

100

Registered

2016-08-27

Start date

2016-08-26

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, bone marrow failure syndrome, and other hematological disorders which requires hematopoietic stem cell transplantaiton

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 hamatologic disorder who need hematopoietic stem cell transplantation who fulfill the following, 1) age under 70 years old 2) written informed consent 3) no available donor with matched or 1 antigin-mismatched HLA in HLA A, B, and DR. 4) no available donor in BM bank, or no time for waiting the cordination due to urgent transplantation 5) available HLA 2-3 antigen-mismatched donor in family members 6) In a case of high risk diseases, patient can select matched or HLA 1 antigen-mismatched donor (if any) or HLA 2-3 antigen-mismatched donor 7) PS 0-2 8) EF>50%, SpO2>93%, T-Bil<2mg/dl, AST<2.5*institutional upper limit, Cre<1.5*institutional upper limit

Exclusion criteria

Exclusion criteria: 1) allergic for drugs used in this protocol 2) active CNS lesion (exclude original disease) 3) active infection 4) when the physician in chief decides the patient is inappropriate for this protocol

Design outcomes

Primary

Measure	Time frame
survival rate on day 100 after transplantation	—

Countries

Japan

Contacts

Public ContactKazuhiro Ikegame

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

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

Outcome results

None listed

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