aggressive adult T cell leukemia/lymphoma
Conditions
Interventions
Haploidentical hematopoietic stem cell transplantation using posttransplant cyclophosphamide for adult T cell leukemia/lymphoma
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are considered eligible when all criteria are met (1) acute or lymphoma type (2) no HLA identical or HLA 1 locus-mismatched related or unrelated donor, or need urgent HSCT (3) HLA haploidentical related donor is available (4) age: 18-65 (5) ECOG PS 0 or 1 (6) disease status: CR, PR, SD (7) written consent is obtained (8) are expected to survive at least 3 months or longer
Exclusion criteria
Exclusion criteria: Patients who meet any criteria below are ineligible (1) severe organ failure (2) uncontrolled hypertension (3) HIV infection (4) uncontrolled infection (5) uncontrolled CNS invasion (6) pregnant/lactating (7) psychological disorder (8) known allergy for drugs used as GVHD prophylaxis or conditioning regimen (9) history of administration of anti-CCR4 antibody (10) high titer of anti-donor specific HLA antibody (11) the physician considers inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival at day 60 after transplantation with engraftment and without grade III-IV acute GVHD | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) 1-year OS/PFS (2) 1-year NRM (3) graft failure (4) time to engraftment, complete chimerism (5) acute/chronic GVHD (6) regimen-related toxicity CTCAE ver 4.0 (7) relapse rate (8) incidence of bacterial, fungal, viral infection (9) immune reconstitution | — |
Countries
Japan
Contacts
Public ContactShigeo Fuji
National Cancer Center Hospital Department of hematopoietic stem cell transplantation
Outcome results
None listed