extranodal NK/T-cell lymphoma, nasal type
Conditions
Interventions
Sponsors
NK-cell Tumor Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histological or cytological diagnosis of extranodal NK/T-cell lymphoma, nasal type, according to the WHO classification. Diagnostic samples should be obtained by surgical or needle biopsy, bone marrow aspiration/biopsy, or peripheral blood cytology. [Notes: Tumor cells must show immunophenotype of NK/T-cells. They should be CD56-positive and CD20-negative either by immunohistochemistry (IHC) or by flow-cytometry (FCM). For CD56-negative cases, they must be CD3epsilon-positive and CD20-negative by IHC/FCM, and positive for EBV either by Southern blotting or by in-situ hybridization (EBER). At least one cytotoxic molecule (perforin, granzyme B or TIA-1) must be positive.] 2) Disease state must be either of the following: i) Newly diagnosed Ann Arbor stage IV cases before any chemotherapy ii) First relapsed/recurrent cases after remission (complete or partial). No chemotherapy or radiotherapy are given within 21 days before registration. iii) Refractory (either NC or PD) cases with first-line chemotherapy. No chemotherapy or radiotherapy are given within 21 days before registration. 3) Age 15-69 years 4) Performance status (ECOG) 0-2 5) At least one evaluable lesion 6) Patients who received corticosteroids alone are eligible for this study, but those under treatment must be discontinued before registration 7) Patients with sufficient hematopoietic (except for cases with bone marrow involvement or HPS), hepatic, renal, cardiac, and pulmonary function 8) Patient's written informed consent before registration.
Exclusion criteria
Exclusion criteria: (1) History of hematopoietic stem cell transplant within 12 months (2) History of allogeneic transplantation (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 or cardiomyopathy (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 |
|---|---|
| overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| complete response rate (%CR), 1-year overall survival, response stratified by frontline/relapsed/refractory categorization, response stratified by the prior regimen of chemotherapy (CHOP-like vs. DeVIC-like), and the rate of adverse events | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactMotoko Yamaguchi
Study Coordinator of SMILE-PII Department of Hematology and Oncology, Mie University Graduate School of Medicine
Outcome results
None listed