Hematological malignancy
Conditions
Interventions
Haploidentical HSCT with a RIC regimen using posttransplant CY as GVHD prophylaxis
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) high-risk hematological malignancy (2) patients who do not have an HLA matched related donor or unrelated donor (3) patients who have an HLA haploidentical related donor (4) Age: >=18, <=65 years old (5) ECOG PS 0 or 1 (6) patients with informed consent (7) patients who are expected to survival at least 3 months (8) patients who are ineligible for a myeloablative conditioning regimen
Exclusion criteria
Exclusion criteria: (1) severe organ dysfunction (2) uncontrolled hypertenstion (3) HIV (4) uncontrolled active infection (5) uncontrolled CNS disease (6) pregnant (7) uncontrolled mental disorder (8) allergy to drugs used as conditioning regimen or GVHD prophylaxis (9) recent high-dose chemotherapy (10) patients whom the physician regard as inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Day 60 survival with engraftment without grade III-IV acute GVHD | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) 1-year OS and PFS (2) 1-year NRM (3) graft failure (4) time to engraftment and complete donor chimerism (5) acute/chronic GVHD (6) regimen-related toxicity (CTCAE ver 4.0) (7) relapse (8) infection (bacterial, fungal, viral) (9) immune reconstitution | — |
Countries
Japan
Contacts
Public ContactShigeo Fuji
National Cancer Center Hospital Hematopoietic Cell Transplantation Division
Outcome results
None listed