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

Salvage haploidentical allogeneic hematopoietic stem cell transplantation using posttransplant cyclophosphamide for engraftment failure (JSCT Salvage PTCy-Haplo)

Onizuka Makoto

Tokai University Hospital

143 Shimokasuya, Isehara, Kanagawa, Japan

moni5@mac.com

Harada Kaito

Tokai University Hospital

143 Shimokasuya, Isehara, Kanagawa, Japan

+81-463-93-1121

kharada@tokai.ac.jp

Recruiting

Feb. 02, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

Both

engraftment failure after allogeneic hematopoietic stem cell transplantation

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

engraftment failure

Haploidentical salvage stem cell transplantation

D006084

D018380

Overall survival at 1 year

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

+81-463-93-1121

Dec. 23, 2022

No

none