UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Autologous peripheral blood stem cell transplantation using MEAM regimen with HAART for refractory and relapsed HIV associated lymphoma: multicentered phase2 clinical trial
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shotaro Hagiwara
Organization	National Center for Global Health and Medicine
Division name	Division of Hematology
Address	1-21-1Toyama, Shinjuku, Tokyo
TEL	81-3-3202-7181
Email	shagiwar@hosp.ncgm.go.jp

Public contact
Name of contact person	Shotaro Hagiwara
Organization	National Center for Global Health and Medicine
Division name	Division of Hematology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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