UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003159 |
|---|---|
| Receipt number | R000003833 |
| Scientific Title | Autologous peripheral blood stem cell transplantation using MEAM regimen with HAART for refractory and relapsed HIV associated lymphoma: multicentered phase2 clinical trial |
| Date of disclosure of the study information | 2010/02/10 |
| Last modified on | 2016/06/16 07:21:19 |
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Basic information
Public title
Autologous peripheral blood stem cell transplantation using MEAM regimen with HAART for refractory and relapsed HIV associated lymphoma: multicentered phase2 clinical trial
Acronym
Auto PBSCT for refractory and relapsed HIV associated lymphoma (ARL209)
Scientific Title
Autologous peripheral blood stem cell transplantation using MEAM regimen with HAART for refractory and relapsed HIV associated lymphoma: multicentered phase2 clinical trial
Scientific Title:Acronym
Auto PBSCT for refractory and relapsed HIV associated lymphoma (ARL209)
Region
| Japan |
Condition
Condition
Refractory and relapsed HIV associated lymphoma
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of autologous stem cell transplantation for refractory and relapsed HIV associated lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Engraftment and survival at day 100 post transplantation
Key secondary outcomes
1year and 2year overall survival
progression free survival
event free survival
therapy related toxicity
remission rate
number of CD4 positive cell and quantity of HIV-RNA
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 | Maneuver |
Interventions/Control_1
autologous stem cell transplantation using MEAM regimen
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HIV positive
refractory to first line chemotherapy and relapsed HIV associated lymphoma
Key exclusion criteria
heart failure, live dysfunction, renal dysfunction
uncontrollable opportunistic infection
uncontrollable diabetes
uncontrollable HIV infection by HAART
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shotaro Hagiwara |
Organization
National Center for Global Health and Medicine
Division name
Division of Hematology
Zip code
Address
1-21-1Toyama, Shinjuku, Tokyo
TEL
81-3-3202-7181
shagiwar@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shotaro Hagiwara |
Organization
National Center for Global Health and Medicine
Division name
Division of Hematology
Zip code
Address
1-21-1Toyama, Shinjuku, Tokyo, JAPAN
TEL
+81-3-3202-7181
Homepage URL
shagiwar@hosp.ncgm.go.jp
Sponsor or person
Institute
Research fund of Ministry Health, Labour and Welfare for a counter measure against AIDS, Okada group and Tanabe group
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2010 | Year | 02 | Month | 10 | 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
| 2010 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | 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
| 2010 | Year | 02 | Month | 09 | Day |
Last modified on
| 2016 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003833
