Salvage haploidentical allogeneic hematopoietic stem cell transplantation using posttransplant cyclophosphamide for engraftment failure

Phase II study of salvage haploidentical allogeneic hematopoietic stem cell transplantation using posttransplant cyclophosphamide for engraftment failure - JSCT Salvage PTCy-Haplo

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031220607

Enrollment

Registered

2023-02-02

Start date

2023-07-05

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

engraftment failure after allogeneic hematopoietic stem cell transplantation engraftment failure

Interventions

Conditioning with fludarabine of 90 mg/m2, melphalan of 40mg/m2, and 2 Gy total body irradiation, followed by salvage hematopoietic stem cell transplantation by haploidentical related donor

D018380

Haploidentical salvage stem cell transplantation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. primary engraftment failure after allogeneic hematopoietic stem cell transplantation for hematological disease, primary immunodeficiency, and congenital metabolic disorder 2. any stage and disease status 3. Age =50, total bilirubin =30, SpO2 >=90% (O2 <=4L/min) 7. consent to join this study 8. a HLA haploidentical donor is available

Exclusion criteria

Exclusion criteria: 1. positive anti-HIV antibody 2. active cancer 3. need for vasopressor 4. pregnancy 5. allergic to cyclophosphamide, melphalan, fludarabine, tacrolimus, and mycophenolate Mofetil 6. need for chemotherapy before protocol therapy 7. concomitant relapse of primary malignancy 8. recurrent engraftment failure 9. presence of donor-specific anti-HLA antibody 10. judgment by physician

Design outcomes

Primary

Measure	Time frame
Overall survival at 1 year	—

Secondary

Measure	Time frame
1. neutrophil and platelet engraftment rate at 30 days 2. incidence and severity of acute and chronic GVHD at 180 and 365 days 3. relapse rate at 180 and 365 days 4. nonrelapse mortality at 180 and 365 days 5. relapse-free survival at 180 and 365 days 6. GVHD-free relapse-free survival at 180 and 365 days 7. incidence of infection at 180 days 8. incidence of non-hematological toxicity graded>=3 at 100 days	—

Measure

Time frame

1. neutrophil and platelet engraftment rate at 30 days 2. incidence and severity of acute and chronic GVHD at 180 and 365 days 3. relapse rate at 180 and 365 days 4. nonrelapse mortality at 180 and 365 days 5. relapse-free survival at 180 and 365 days 6. GVHD-free relapse-free survival at 180 and 365 days 7. incidence of infection at 180 days 8. incidence of non-hematological toxicity graded>=3 at 100 days

—

Contacts

Public ContactKaito Harada

Tokai University Hospital

kharada@tokai.ac.jp+81-463-93-1121

Outcome results

None listed

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