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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002747
Receipt No. R000003342
Scientific Title Phase II study of SMILE chemotherapy for relapsed/refractory mature T-cell lymphoma
Date of disclosure of the study information 2009/11/18
Last modified on 2014/05/12

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Basic information
Public title Phase II study of SMILE chemotherapy for relapsed/refractory mature T-cell lymphoma
Acronym Phase II study of SMILE chemotherapy for relapsed/refractory mature T-cell lymphoma
Scientific Title Phase II study of SMILE chemotherapy for relapsed/refractory mature T-cell lymphoma
Scientific Title:Acronym Phase II study of SMILE chemotherapy for relapsed/refractory mature T-cell lymphoma
Region
Japan Asia(except Japan)

Condition
Condition Mature T cell lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish a more effective therapy for mature T-cell lymphoma with relapsed/refractory state, we plan a safety and efficacy study of SMILE (Steroid=dexamethasone, Methotrexate, Ifosfamide, L-asparaginase and Etoposide) regimen.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall response rate
Key secondary outcomes complete response rate (%CR), 1-year overall survival, response stratified by relapsed/refractory categorization,
response stratified by disease subtype, and the rate of adverse events

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) Histological or cytological diagnosis of mature T-cell lymphoma, according to the WHO classification 4th edition. The following 8 disease categories are eligible.( Peripheral T-cell lymphoma,not otherwise specified, Angioimmunoblastic T-cell lymphoma, Anaplastic large cell lymphoma,ALK-positive, Anaplastic large cell lymphoma,ALK-negative, Hepatosplenic T-cell lymophoma, Enteropathy-associated T-cell lymphoma,Primary cutaneous ganmma-delta T-cell lymphoma, Primary cutaneous CD8 positive aggressive epidermotropic cytotoxic T-cell lymphoma
2) Disease state must be either of the following:
i) First relapsed/recurrent cases after remission (complete or partial). No chemotherapy or radiotherapy are given within 21 days before registration.
ii) Refractory (either SD or PD) cases with first-line chemotherapy. No chemotherapy or radiotherapy are given within 21 days before registration.
3) Age 15-69 years
4) Performance status (ECOG) 0-2
5) At least one evaluable lesion
6) Patients who received corticosteroids alone are eligible for this study, but those under treatment must be discontinued before registration
7) Patients with sufficient hematopoietic (except for cases with bone marrow involvement or HPS), hepatic, renal, cardiac, and pulmonary function
8) Patient's written informed consent before registration.
Key exclusion 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
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ritsuro Suzuki
Organization Nagoya University School of Medicine
Division name Department of HSCT Data Management & Biostatistics
Zip code
Address 1-1-20 Daiko-minami,Higashi-ku,Nagoya 461-0047,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ritsuro Suzuki
Organization Nagoya University School of Medicine
Division name Department of HSCT Data Management & Biostatistics
Zip code
Address
TEL 052-719-1973
Homepage URL
Email r-suzuki@med.nagoya-u.ac.jp

Sponsor
Institute NK-cell Tumor Study Group
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding 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
2009 Year 11 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 No longer recruiting
Date of protocol fixation
2009 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2015 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 11 Day
Last modified on
2014 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003342

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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