extranodal NK/T-cell lymphoma, nasal type or cytological diagnosis of aggressive NK-cell leukemia according to the WHO Classification
Conditions
Interventions
Sponsors
NK-cell Tumor Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histopathological diagnosis of extranodal NK/T-cell lymphoma, nasal type or cytological diagnosis of aggressive NK cell leukemia according to the WHO Classification 2) Disease state must be either of the following: A)Newly diagnosed Ann Arbor stage IV cases (including aggressive NK-cell leukemia) before chemotherapy (corticosteroids are permitted) B)First relapse/recurrent cases after remission (complete or partial) C)Refractory (either NC or PD) cases with first-line chemotherapy 3) Age 15-69 years 4) Performance status 0-2 5) At least one evaluable lesion 6) For patients using systemic steroid hormone, it must be discontinued before registration. 7) Adequate bone marrow (excluding stage IV cases), hepatic, renal, cardiac and pulmonary function 8) Patient's written informed consent registration
Exclusion criteria
Exclusion criteria: (1)Previous history of stem cell transplantation (2)Skin as the only affected site of involvement (3)Clinical symptoms of CNS involvement (CSF cytology or brain MRI imaging are not required) (4)Need for radiation more than 15 Gy including palliation at the time of registration (5)History of serious adverse reaction(s) by agents including SMILE chemotherapy (Example: allergy for L-asparaginase, delayed excretion of methotrexate, etc.) (6)Pleural effusion or ascites except for those with little amount, which cannot be performed pleural or abdominal puncture (7)Uncontrollable hypertension (8)History of myocardial infarction or angina, cardiomyopathy, or arrhythmia under drug treatment (9)HBs antigen positive (10)HIV antibody positive (11)Accompanying interstitial pneumonitis, pulmonary fibrosis, or severe emphysema (all apparently diagnosed by chest X-ray) (12)Severe infections (13)Liver cirrhosis, either biopsy proven or clinically diagnosed (14)Active double cancer: overlapping cancer or asynchronous cancer within 5 years. Carcinoma in situ, intramucosal cancers, and other equivalent lesions are not included for the active double cancer. (15)Women during pregnancy, lactation period or of childbearing potentials not using a reliable contraceptive method (16)Use of major tranquilizer, antidepressant, or antimanic (17)Severe psychosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum tolerated dose (MTD) | — |
Secondary
| Measure | Time frame |
|---|---|
| the overall response rate and the complete response rate. | — |
Countries
Japan,Asia(except Japan)
Outcome results
None listed