UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014902 |
|---|---|
| Receipt number | R000017333 |
| Scientific Title | A multicenter phase II study for previouly untreated advanced stage peripheral T-cell lymphoma evaluating efficacy and safety of combination chemotherapy with THP-COP regimen |
| Date of disclosure of the study information | 2014/08/20 |
| Last modified on | 2014/08/20 13:45:43 |
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Basic information
Public title
A multicenter phase II study for previouly untreated advanced stage peripheral T-cell lymphoma evaluating efficacy and safety of combination chemotherapy with THP-COP regimen
Acronym
A phase II study of THP-COP therapy for previouly untreated advanced stage peripheral T-cell lymphoma.
Scientific Title
A multicenter phase II study for previouly untreated advanced stage peripheral T-cell lymphoma evaluating efficacy and safety of combination chemotherapy with THP-COP regimen
Scientific Title:Acronym
A phase II study of THP-COP therapy for previouly untreated advanced stage peripheral T-cell lymphoma.
Region
| Japan |
Condition
Condition
previouly untreated advanced stage peripheral T-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A multicenter phase II study in previouly untreated advanced stage peripheral T-cell lymphoma evaluating efficacy and safety of combination chemotherapy with THP-COP regimen
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
complete response rate, %CR
Key secondary outcomes
1) short-term safety
2) response rate (%RR)
3) 1year progression-free survival (1-y PFS)
4) 1year overall survival (1-y OS)
5)long-term safety
Base
Study type
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
Chemotherapy (Age20-69: 8 cycles and 70-79: 6 cycles of R-THP-COP therapy)
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histological confirmed Peripheral T-cell lymphoma including unspecified (PTCL-u), Angioimmunoblatic T-cell lymphoma (AITL) and Anaplastic large cell lymphoma (ALCL) excluding ETL, HSTCL, SPTCL and ATLL (WHO)
2. Clinical stage of bulky II, III or IV according to Ann Arbor classification
3. Aged 20-79 years
4. Performance status of 0-2
5. Presence of measurable lesion(s)
6. No prior chemotherapy, radiotherapy, interferon and/or antibody therapy
7. Patients with sufficient organ functions
8. Patient's written informed consent
Key exclusion criteria
1. Presence of central nervous involvement (clinical or pathological)
2. Diabetes mellitus receiving insulin therapy
3. Uncontrollable hypertension
4. History of angina pectoris or myocardial infarction. Comorbidity of cardiomyopathy. Arrhythmia on treatment with antiarrhythmic agents
5. Positive test for HBs antigen
6. Positive test for HCV antibody
7. Positive test for HIV antibody
8. Accompanying interstitial pneumonitis, pulmonary fibrosis or severe emphysema diagnosed by chest X-ray
9. Severe infection
10. Biopsy proven or clinically diagnosed Liver cirrhosis
11. 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
12. Use of major tranquilizer, antidepressant or antimanic drugs
13. Severe psychosis
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michinori Ogura |
Organization
National Hospital Organization Suzuka National Hospital
Division name
Department of Internal Mediciney & Laboratory Medicine
Zip code
Address
Kasado 3-2-1, Suzuka, Mie, 513-8501, Japan
TEL
059-378-1321
mi-ogura@naa.att.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michinori Ogura |
Organization
Hematological Malignancy Study Group
Division name
Hematological Malignancy Study Group
Zip code
Address
Kasado 3-2-1, Suzuka, Mie, 513-8501, Japan
TEL
059-378-1321
Homepage URL
http://www.hmcsg.umin.jp/
mi-ogura@naa.att.ne.jp
Sponsor or person
Institute
Hematological Malignancy Study Group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 08 | Month | 20 | 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
| 2007 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 20 | Day |
Last modified on
| 2014 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017333
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