Salvage haploidentical allogeneic hematopoietic stem cell transplantation using posttransplant cyclophosphamide for engraftment failure
- Conditions
- engraftment failureD006084engraftment failure after allogeneic hematopoietic stem cell transplantation
- Registration Number
- JPRN-jRCTs031220607
- Lead Sponsor
- Onizuka Makoto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
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 <= 70
4. PS 0-3
5. any history of autologous or allogeneic stem cell transplantation
6. no evidence of severe organ dysfunction (ejection fraction >=50, total bilirubin <=2.0, CCr >=30, SpO2 >=90% (O2 <=4L/min)
7. consent to join this study
8. a HLA haploidentical donor is available
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival at 1 year
- Secondary Outcome Measures
Name Time Method 1. neutrophil and platelet engraftment rate at 30 days<br>2. incidence and severity of acute and chronic GVHD at 180 and 365 days<br>3. relapse rate at 180 and 365 days<br>4. nonrelapse mortality at 180 and 365 days<br>5. relapse-free survival at 180 and 365 days<br>6. GVHD-free relapse-free survival at 180 and 365 days<br>7. incidence of infection at 180 days<br>8. incidence of non-hematological toxicity graded>=3 at 100 days