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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001181
Receipt No. R000001431
Scientific Title Salvage chemotherapy followed by autoSCT for relapsed HIV associated lymphoma
Date of disclosure of the study information 2008/06/10
Last modified on 2016/12/16

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Basic information
Public title Salvage chemotherapy followed by autoSCT for relapsed HIV associated lymphoma
Acronym Salvage chemotherpy for HIV associated lymphoma
Scientific Title Salvage chemotherapy followed by autoSCT for relapsed HIV associated lymphoma
Scientific Title:Acronym Salvage chemotherpy for HIV associated lymphoma
Region
Japan

Condition
Condition Relapsed or refractory HIV associated lymphoma
Classification by specialty
Hematology and clinical oncology Infectious disease
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety, and efficacy of modified ESHAP followed by autologous peripheral blood stem cell transplantation as a salvage chemotherapy for refractory or relapsed HIV-associated lymphoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 2year over all survival
Key secondary outcomes survival at 100 days after transplantation, CR rate, therapy related toxicity, the number of collected stem cells, the rate of engraftment, the number of CD4 positive cells, the quantity of HIV-virus

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 Salvage regimen;
etoposide60mg/m2 div for 2hrs day1-4
mPSL500mg div for 30min day1-5
carboplatin100mg/m2 cont.div day1-4
AraC2g/m2 div for 3hrs day5
Rituximab375mg div day1 for a case with CD20 positive
1course=21days, 1-4courses

Peripheral blood stem cells should be collected after 1-4 course using G-CSF

Patients who achieved PR or CR after 1-4courses of salvage regimen, should be treated with MEAM regimen followed by autologous peripheral blood stem cell transplantation.

More than 2x10E6/kg of CD34-posiive cells should be infused on day0.

MEAM regimen;
MCNU300mg/m2 div for 1hr day-6
etoposide200mg/m2 div for 3hrs day-5~-3
AraC200mg/m2 div for 3 hrs day-5~-3
L-PAM140mg/m2 bolus iv day-2
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
15 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria Inclusion criteria for salvage regimen;
1)HIV positive
2)refractory to first line chemotherapy or relapsed non-Hodgkin's lymphoma
3)ECOG PS0-4
4)Well controlled HIV rirul load with HAART
5)Written informed consent sheet must be obtained before entry to the trial

Inclusion criteria for autologous peripheral blood stem cell transplantation;
1)More than 2x10E6/kg of CD34-positive cells were collected
2)Patients who achieved PR or CR after the salvage regimen
3)Age:15=< <60
4)ECOG PS0-2
5)HIV virus load should be well controlled with HAART
6)No active opportunistic infection
7)Written informed consent sheet must be obtained

Key exclusion criteria Exclusion criteria for salvage regimen
1)Organ dysfunction
a)EF<40% by cardiac sonography
b)PaO2<50mmHg or SaO2<90%
c)serumCr>3.0mg/dl
d)Total-bilirubin>3.0mg/dl or ALT>five times upper limit of the institutional normal value
2)Serious active infection
Exclusion criteria for PBSCT
1)Organ dysfunction
a)EF<50% by cardiac sonography
b)PaO2<60mmHg
c)serumCr>2.0mg/dl
d)Total-bilirubin>2.0mg/dl or ALT>twice of upper limit of the institutional normal value
2)Uncontrollable HIV virus load and resistant to HAART
3)Uncontrollable diabetes which is resistant to insulin
4)Uncontrollable hypertension
5)Intractable and active infection
6)Intractable invasion of lymphoma to CNS
7)Pregnant or possible pregnant women or breast feeding


Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shotaro Hagiwara
Organization International Medical Center of JAPAN
Division name Division of Hematology
Zip code
Address 1-21-1Toyama, Shinjuku, Tokyo
TEL 03-3202-7181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shotaro Hagiwara
Organization International Medical Center of JAPAN
Division name Division of Hematology
Zip code
Address
TEL
Homepage URL
Email shagiwar@imcj.hosp.go.jp

Sponsor
Institute International Medical Center of JAPAN
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization JAPAN

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
2008 Year 06 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 Completed
Date of protocol fixation
2008 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2014 Year 06 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 06 Month 10 Day
Last modified on
2016 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001431

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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