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A study of haploidentical transplantation with post-transplant cyclophosphamide

A study of haploidentical transplantation with post-transplant cyclophosphamide - A study of haploidentical transplantation with post-transplant cyclophosphamide

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019089
Enrollment
40
Registered
2015-09-25
Start date
2013-06-27
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

AML,ALL,MDS,NHL,MM,CML

Interventions

GVHD prophilaxis Cyclophosphamide 50mg/kg iv day3,4(or 5)

Sponsors

Department of Hematology, Kanazawa University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. patients who have hematologic malignancies and who are eligible for allogenic transplantation. 2. Age 15-70 years 3. 2nd CR or subsequent CR, nonCR. 1st CR as defined at least one of folloing: a) Acute lymphoblastic leukemia Intermediate or Poor risk as defined by NCCN guidelines b) Acute Myelogenous Leukemia Greater than 1 cycle of induction therapy required to achieve remission, Intedmediate or High risk as defined by NCCN guidelines Monosomal karyotype ckit mutations with t(8;21), inv(16), t(16;16) t(7;11)(p15;p15) Preceding myelodysplastic syndrome c) Myelodysplastic syndrome high, very high as defined by WHO classification-based Prognostic Scoring System Patients who have receive ten units or more platelet transfusions per week, or two units or more RBC transfusions per month. 4. Patients who have no HLA-matched or 7/8 matched related donor. 5. Patients who have no HLA-matched or 7/8 matched unrelated donor. 6. Patients who given written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients who are positive for HBs antigen, HCV antibody, or HIV antibody. 2. Patients with active other malignancies. 3. Women who are pregnant, of childbearing potential, or lactating. 4. Patients who experienced serious hypersensitivity or anaphylaxis to cyclophosphamide. 5. patients who are not eligble for this study at the discretion of the investigator.

Design outcomes

Primary

MeasureTime frame
treatment related mortality within 100days

Secondary

MeasureTime frame
1. overall survival, event free survival, relapse rate at 100 days 2. overall survival, event free survival, relapse rate at 1 year 3. neutrophilans platlet engraftment 4. engraftment failure 5. complete chimerism 6. acute GVHD 7. chronic GVHD 8. infectious event 9. grade 3-4 toxicity within 100 days

Countries

Japan

Contacts

Public ContactKinya Ohata

Kanazawa University Hospital Department of Hematology

ohata.521222@gmail.com076-265-2275

Outcome results

None listed

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