UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001452 |
|---|---|
| Receipt number | R000001757 |
| Scientific Title | A clinical trial of R-CHOP with antiretroviral therapy for newly diagnosed CD20 positive AIDS-related non-Hodgkin lymphoma |
| Date of disclosure of the study information | 2008/10/23 |
| Last modified on | 2013/02/07 11:19:35 |
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Basic information
Public title
A clinical trial of R-CHOP with antiretroviral therapy for newly diagnosed CD20 positive AIDS-related non-Hodgkin lymphoma
Acronym
R-CHOP and HAART for AIDS-related NHL
Scientific Title
A clinical trial of R-CHOP with antiretroviral therapy for newly diagnosed CD20 positive AIDS-related non-Hodgkin lymphoma
Scientific Title:Acronym
R-CHOP and HAART for AIDS-related NHL
Region
| Japan |
Condition
Condition
Newly diagnosed CD20 positive AIDS-related non-Hodgkin lymphoma
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the outcome of R-CHOP combined with HAART for AIDS-related non-Hodgkin lymphoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The 2-year progression-free survival
Key secondary outcomes
The 2-year overall survival, remission rate, toxicity, and the incidence of opportunistic infections
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
R-CHOP with HAART
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)HIV positive
2)Pathologically confirmed CD20-positive non-Hodgkin lymphoma
3)aged 20 to 64
4)ECOG performance status score 0-3
5)Written informed consent
Key exclusion criteria
1)Burkitt's lymphoma
2)CNS involvement
3)Uncontrolled opportunistic infections
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junko Tanuma |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
Address
1-21-1, Toyama, Shinjuku, Tokyo
TEL
03-3202-7181
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Tanuma |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
Address
TEL
Homepage URL
jtanuma@acc.ncgm.go.jp
Sponsor or person
Institute
AIDS Clinical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2008 | Year | 10 | Month | 23 | 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
| 2007 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | 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
| 2008 | Year | 10 | Month | 22 | Day |
Last modified on
| 2013 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001757
