UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002747 |
|---|---|
| Receipt number | 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 08:25:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
r-suzuki@med.nagoya-u.ac.jp
Sponsor or person
Institute
NK-cell Tumor Study Group
Institute
Department
Personal name
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
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
Value
https://center6.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 |
