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

UMIN ID: C000000018

Registered date:04/07/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: extranodal NK/T-cell lymphoma, nasal type or cytological diagnosis of aggressive NK-cell leukemia according to the WHO Classification
• Date of first enrollment: 2005/07/01
• Target sample size: 24
• Countries of recruitment: Japan,Asia(except Japan)
• Study type: Interventional
• Intervention(s): Two cycles of SMILE chemotherapy consisting from steroid, methotrexate, ifosfamide, L-asparaginase, and etoposide.

Outcome(s)

• Primary Outcome: maximum tolerated dose (MTD)
• Secondary Outcome: the overall response rate and the complete response rate.

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 69years-old
• Gender: Male and Female
• 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

• Primary Sponsor: NK-cell Tumor Study Group
• Source(s) of Monetary Support: Kirin Brewery Co., LTD.