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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003159
Receipt No. 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

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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
Email 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
Email shagiwar@hosp.ncgm.go.jp

Sponsor
Institute Research fund of Ministry Health, Labour and Welfare for a counter measure against AIDS, Okada group and Tanabe group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003833

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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