A phase II study of haploidentical transplantation with post-transplantation cyclophosphamide following reduced-intensity conditioning

A phase II study of haploidentical transplantation with post-transplantation cyclophosphamide following reduced-intensity conditioning - JSCT Haplo16 RIC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020656

Enrollment

Registered

2016-01-20

Start date

2016-04-01

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

Interventions

The preparative regimen will consist of : Fludarabine 30mg/m2 IV Days -6, -5, -4, -3, -2 Busulfan 3.2mg/kg IV Days -4, -3 Total body irradiation (TBI) 4Gy Day -1 The GVHD prophylaxis regimen wi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who have hematologic malignancies and who are eligible for allogeneic stem cell transplantation following reduced-intensity conditioning 2. Any disease status 3. Age: 15-70 years old 4. Any prior history of hematopoietic stem cell transplantation 5. Performance status: 0-2 6. Patients with adequate physical function (Cardiac, Hepatic, Renal, Pulmonary). 7. Patients who have no HLA-matched related donor. 8. Patients who have no HLA-matched related donor. 9. Patients who are not eligible for allogeneic stem cell transplantation following myeloablative conditioning. 10. Patients who give 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. Patients with active infectious disease. 4. Women who are pregnant, of childbearing potential, or lactating. 5. Patients who experienced serious hypersensitivity or anaphylaxis to cyclophosphamide, fludarabine, tacrolimus, mycophenolate mofetil. 6. Positive anti-donor HLA antibody. 7. Patients who need chemotherapy within 13 days before transplantation. 8. Patients whose body mass index is >=30. 9. Patients who are not eligible for this study at the discretion of the investigator.

Design outcomes

Primary

Measure	Time frame
The incidence of grade III-IV acute GVHD at 100 days	—

Secondary

Measure	Time frame
1. Engraftment at 100 days. 2. The incidence of acute GVHD and chronic GVHD at 100 days, 1 year, and 2 years. 3. Non-relapse mortality at 100 days, 1 year, and 2 years. 4. The incidence of relapse at 100 days, 1 year, and 2 years. 5. Disease-free survival at 100 days, 1 year, and 2 years. 6. Overall survival at 100 days, 1 year, and 2 years. 7. The incidence of infectious event at 100 days, 1 year, and 2 years. 8. GVHD free, relapse free survival (GRFS) at 100 days, 1 year, and 2 years. 9. The proportion of patients who stopped immunosuppressive drugs within 1 year and 2 year. 10. Noninfectious fever within 7 days after transplantation 11. Grade 3-4 non-hematologic toxicity within 100 days. 12. Subgroup analysis subgroup analysis according to disease risk index (DRI)	—

Measure

Time frame

1. Engraftment at 100 days. 2. The incidence of acute GVHD and chronic GVHD at 100 days, 1 year, and 2 years. 3. Non-relapse mortality at 100 days, 1 year, and 2 years. 4. The incidence of relapse at 100 days, 1 year, and 2 years. 5. Disease-free survival at 100 days, 1 year, and 2 years. 6. Overall survival at 100 days, 1 year, and 2 years. 7. The incidence of infectious event at 100 days, 1 year, and 2 years. 8. GVHD free, relapse free survival (GRFS) at 100 days, 1 year, and 2 years. 9. The proportion of patients who stopped immunosuppressive drugs within 1 year and 2 year. 10. Noninfectious fever within 7 days after transplantation 11. Grade 3-4 non-hematologic toxicity within 100 days. 12. Subgroup analysis subgroup analysis according to disease risk index (DRI)

—

Countries

Japan

Contacts

Public ContactJunichi Sugita

JSCT Haplo16 DC

jsct-office@umin.ac.jp03-6225-2025

Outcome results

None listed

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