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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010485
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Yokohama City University Hopsital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012258

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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