adult T-cell leukemia/lymphoma
Conditions
Interventions
(1) Unrelated peripheral blood stem cell transplantation
(2) GVHD prophylaxis with post-transplant cyclophosphamide(PTCY)
GVHD prophylaxis consists of tacrolimus starting at 0.02-0.03 mg/kg/day on day
Sponsors
Fukuda Takahiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult T-cell leukemia/lymphoma, acute or lymphoma type 2) Patients who have an HLA 6-8/8 matched unrelated peripheral blood stem cell donor 3) Age: 20-65 years old 4) ECOG performance status: 0 or 1 5) Disease status: CR, PR, or, SD 6) Written informed consent from the patient 7) Patients who are expected to survive for at least 3 months
Exclusion criteria
Exclusion criteria: 1) Severe organ dysfunction in the heart, lung, kidney, or liver 2) Uncontrollable ATL lesion in central nervous system 3) Uncontrollable diabetes mellitus 4) Uncontrollable hypertension 5) Coronary artery disease requiring treatment, cardiomyopathy, cardiac failure, or arrhythmia requiring medication 6) Acute hepatitis, chronic active hepatitis, or liver cirrhosis 7) Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest X-ray. 8) Infectious disease requiring systemic therapy 9) Simultaneous or metachronous (within 5 years) double cancers, except for carcinoma in situ resected by local therapy 10) History of lymphoma, myelodysplastic syndrome, or leukemia 11) History of anti-CCR4 antibody administration 12) Prior hematopoietic stem cell transplantation 13) High titer of anti-donor specific HLA antibody 14) Positive HIV antibody 15) Women during pregnancy or breastfeeding 16) Psychological disorder 17) Patients who are not eligible for this study at the discretion of the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival without grade III-IV acute GVHD at 100 days after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Incidence and severity of acute and chronic GVHD at 100 days, and 1 year (2) Non-relapse mortality at 100 days, and 1 year (3) Incidence of relapse or progression at 100 days, and 1 year (4) Overall survival and progression-free survival at 100 days, and 1 year (5) Proportion of patients who discontinued immunosuppressive agents at 1 year (6) Grade 3-4 toxicity within 100 days (7) Incidence of infectious disease at 100 days, and 1 year (8) Incidence of primary or secondary graft failure (9) Time to hematological recovery (10) Immune reconstitution | — |
Contacts
Public ContactWataru Takeda
National Cancer Center Hospital
Outcome results
None listed