UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000018 |
|---|---|
| Receipt number | 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 13:22:16 |
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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
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
nkktumor-group@umin.ac.jp
Sponsor or person
Institute
NK-cell Tumor Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000040
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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