NIPH Clinical Trials Search

UMIN ID: C000000018

Registered date:04/07/2005

Phase I study of SMILE chemotherapy for advanced-stage or relapsed/refractory extranodal NK/T-cell lymphoma/leukemia(NK-SMILE-P1)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedextranodal NK/T-cell lymphoma, nasal type or cytological diagnosis of aggressive NK-cell leukemia according to the WHO Classification
Date of first enrollment2005/07/01
Target sample size24
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 Outcomemaximum tolerated dose (MTD)
Secondary Outcomethe overall response rate and the complete response rate.

Key inclusion & exclusion criteria

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

Related Information


public contact
Address Japan
Affiliation NK-cell Tumor Study Group NK-cell Tumor Study Group
scientific contact
Name Kazuo Oshimi
Address Hongo, Bunkyo-ku, Tokyo 113-8421, Japan Japan
Affiliation Juntendo University Department of Hematology