NIPH Clinical Trials Search

UMIN ID: UMIN000000712

Registered date:14/05/2007

Phase II study of SMILE chemotherapy for stage IV or relapsed/refractory extranodal NK/T-cell lymphoma

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedextranodal NK/T-cell lymphoma, nasal type
Date of first enrollment2007/07/01
Target sample size28
Countries of recruitmentJapan,Asia(except Japan)
Study typeInterventional
Intervention(s)Two cycles of SMILE chemotherapy consisting from steroid, methotrexate, ifosfamide, L-asparaginase, and etoposide.


Primary Outcomeoverall response rate
Secondary Outcomecomplete 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

Key inclusion & exclusion criteria

Age minimum15years-old
Age maximum69years-old
GenderMale and Female
Include criteria
Exclude 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

Related Information


public contact
Name Motoko Yamaguchi
Address Japan
Affiliation Study Coordinator of SMILE-PII Department of Hematology and Oncology, Mie University Graduate School of Medicine
scientific contact
Name Kazuo Oshimi
Address Hongo, Bunkyo-ku, Tokyo 113-8421, Japan Japan
Affiliation Juntendo University Department of Hematology