UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010485 |
|---|---|
| Receipt number | R000012258 |
| Scientific Title | Biweekly THP-COP therapy for newly diagnosed peripheral T-cell lymphoma |
| Date of disclosure of the study information | 2013/04/15 |
| Last modified on | 2013/04/13 11:10:08 |
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Basic information
Public title
Biweekly THP-COP therapy for newly diagnosed peripheral T-cell lymphoma
Acronym
Biweekly THP-COP for PTCLs
Scientific Title
Biweekly THP-COP therapy for newly diagnosed peripheral T-cell lymphoma
Scientific Title:Acronym
Biweekly THP-COP for PTCLs
Region
| Japan |
Condition
Condition
Peripheral T-cell lymphoma, not otherwise specified and angioimmunoblastic T-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Establishment of new standard therapy in PTCLs
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response rate and safety
Key secondary outcomes
progression-free survival and overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Six cycles of biweekly THP-COP therapy between 2004 and 2011.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
a. Consecutive new diagnoses with measurable disease representing histologically documented PTCL-nos or AITL according to the World Health Organization classification;
b. pre-study performance status PS score ranging from 0 to 3 on the Eastern Cooperative Oncology Group;
c. 15-69 years of age;
d. any clinical stage;
e. knowledge about their diagnosis and expected prognosis
f. a left ventricular ejection fraction by echocardiography at least 50%
g. a partial pressure of oxygen in the arterial blood at least 60 Torr while breathing ambient air.
h. written informed conscent
Key exclusion criteria
Exclusion criteria were the presence of serious infection; active tuberculosis; diabetes mellitus uncontrollable with insulin, liver cirrhosis, arrhythmia, or other abnormal electrocardiographic finding requiring treatment, concomitant malignant disease other than basal cell carcinoma of the skin or carcinoma in situ of the uteric cervix; central nervous system (CNS) lymphoma; pregnancy or breast feeding; mental disorders; and positivity for hepatitis B surface antigen, human T-lymphotrophic virus-1 antibody, or human immunodeficiency virus antibody. Patients were also excluded if the treating physician considered the protocol too difficult for the patients to carry out.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | NAOTO TOMITA |
Organization
Yokohama City University
Division name
Department of Internal Medicine and Clinical Immunology
Zip code
Address
3-9 Fukuura, Kanazawa, Yokohama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama City University
Division name
Department of Internal Medicine and Clinical Immunology
Zip code
Address
3-9 Fukuura, Kanazawa, Yokohama
TEL
Homepage URL
Sponsor or person
Institute
Yokohama City University Hopsital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 04 | Month | 15 | 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
Completed
Date of protocol fixation
| 2003 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 13 | Day |
Last modified on
| 2013 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012258
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
