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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000018
Receipt No. R000000040
Scientific Title Phase I study of SMILE chemotherapy for advanced-stage or relapsed/refractory extranodal NK/T-cell lymphoma/leukemia(NK-SMILE-P1)
Date of disclosure of the study information 2005/07/04
Last modified on 2008/03/11

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Basic information
Public title Phase I study of SMILE chemotherapy
for advanced-stage or relapsed/refractory
extranodal NK/T-cell lymphoma/leukemia(NK-SMILE-P1)
Acronym Phase I study of SMILE chemotherapy
for advanced-stage or relapsed/refractory
extranodal NK/T-cell lymphoma/leukemia(NK-SMILE-P1)
Scientific Title Phase I study of SMILE chemotherapy
for advanced-stage or relapsed/refractory
extranodal NK/T-cell lymphoma/leukemia(NK-SMILE-P1)
Scientific Title:Acronym Phase I study of SMILE chemotherapy
for advanced-stage or relapsed/refractory
extranodal NK/T-cell lymphoma/leukemia(NK-SMILE-P1)
Region
Japan Asia(except Japan)

Condition
Condition extranodal NK/T-cell lymphoma, nasal type or cytological diagnosis of aggressive NK-cell leukemia according to the WHO Classification
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish a more effective therapy for extranodal NK/T-cell lymphoma, nasal type and aggressive NK-cell leukemia with untreated stage IV or relapsed/refractory state, we plan a dose escalating feasibility study of a newly designed chemotherapeutic regimen, SMILE (Steroid=dexamethasone, Methotrexate, Ifosfamide, L-asparaginase and Etoposide)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes maximum tolerated dose (MTD)
Key secondary outcomes the overall response rate and the complete response rate.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Two cycles of SMILE chemotherapy consisting from steroid, methotrexate, ifosfamide, L-asparaginase, and etoposide.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key 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
Key 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
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Oshimi
Organization Juntendo University
Division name Department of Hematology
Zip code
Address Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization NK-cell Tumor Study Group
Division name NK-cell Tumor Study Group
Zip code
Address
TEL
Homepage URL
Email nkktumor-group@umin.ac.jp

Sponsor
Institute NK-cell Tumor Study Group
Institute
Department

Funding Source
Organization Kirin Brewery Co., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 07 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://nktsg.dip.jp
Number of participants that the trial has enrolled
Results
Yamaguchi et al. Cancer Sci 2008 [Epub]
Phase I study of dexamethasone, methotrexate, ifosfamide, l-asparaginase, and etoposide (SMILE) chemotherapy for advanced-stage, relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma and leukemia.
PMID: 18294294
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2005 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2005 Year 07 Month 01 Day
Last follow-up date
2007 Year 01 Month 01 Day
Date of closure to data entry
2007 Year 03 Month 01 Day
Date trial data considered complete
2007 Year 03 Month 01 Day
Date analysis concluded
2007 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 07 Month 03 Day
Last modified on
2008 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000040

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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