UMIN-CTR Clinical Trial

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

Relapsed or refractory HIV associated lymphoma

Classification by specialty

Hematology and clinical oncology

Infectious disease

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

International Medical Center of JAPAN

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

06

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2008

Year

06

Month

10

Day

Last modified on

2016

Year

12

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001431