UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005636 |
|---|---|
| Receipt number | R000006644 |
| Scientific Title | Phase II study of a full-dose THP-COP regimen for aggressive non-Hodgkin lymphoma in the elderly |
| Date of disclosure of the study information | 2011/05/28 |
| Last modified on | 2011/05/24 12:42:37 |
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Basic information
Public title
Phase II study of a full-dose THP-COP regimen for aggressive non-Hodgkin lymphoma in the elderly
Acronym
THP-1
Scientific Title
Phase II study of a full-dose THP-COP regimen for aggressive non-Hodgkin lymphoma in the elderly
Scientific Title:Acronym
THP-1
Region
| Japan |
Condition
Condition
aggressive non Hodgkin lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of THP-COP in elderly Japanese patients with aggressive NHL
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
CR rate
Key secondary outcomes
failure-free survival
overall survival
toxicity
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
THP-COP
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
| 70 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) 70-79 years old
2) untreated intermediate-high grade NHL
3) clinical stage; I with bulky mass, II-IV
4) PS 0-1
5) adequate organ function as follows;
a) neutrophil > 1.2 x 109/L
b) platelet > 5.0 x 109/L
c) AST and ALT < 5 times the upper limit of the normal
d) total bilirubin < 2.0 mg/dL
e) serum creatinin < 2.0 mg/dL
g) PaO2 > 60 torr
6) written informed consent
Key exclusion criteria
1)Patients with any other malignancies
2)mental illness
3)a history of myocardial infarction or angina
4)central nervous system infiltration
5)uncontrollable diabetes
6)human immunodeficiency virus infection
7) hepatitis B virus surface antigen
8)hepatitis C virus antibody positivity
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomomitsu Hotta |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Division of hematology
Zip code
Address
Nakaku sannnomaru 4-1-1, Nagoya
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Ohmachi |
Organization
Tokai University
Division name
Division of hematology/oncology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Hematological Malignancy Clinical 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
| 2011 | Year | 05 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 1999 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1999 | Year | 01 | 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
| 2011 | Year | 05 | Month | 24 | Day |
Last modified on
| 2011 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006644
