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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000409
Receipt No. R000000499
Scientific Title A multi institutional phase II trial of peripheral blood stem cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen.
Date of disclosure of the study information 2006/05/01
Last modified on 2018/05/07

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Basic information
Public title A multi institutional phase II trial of peripheral blood stem cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen.
Acronym A multi institutional phase II trial of peripheral blood stem cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen (ATL-NST-3).
Scientific Title A multi institutional phase II trial of peripheral blood stem cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen.
Scientific Title:Acronym A multi institutional phase II trial of peripheral blood stem cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen (ATL-NST-3).
Region
Japan

Condition
Condition Adult T cell leukemia/lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the safety and effectiveness of peripheral blood stem cell transplantation for Lymphoma type or acute type of adult T cell leukemia/lymphoma following reduced intensity conditioning regimen.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Over all survival rate at 2 years after transplantation.
Key secondary outcomes 1.Over all survival and progression free survival rate at 100 day after transplantation (at d100).
2.Achievement of complete chimera (Donor derived cell above 90% at d90).
3.Over all survival rate at d180
4.Over all survival and progression free survival rate at d365.
5.Progression free survival at 2 year after transplantation.
6.Time to progression and survival.
7.Toxicity due to conditioning regimen and drugs for acute GVHD prophylaxis.
8.Incidence and Severity of GVHD.
9.Relationship between time to onset of GVHD and chimera.
10.Retationship of GVHD, and anti tumor effect, overall survival or progression free survival rate.
11.Incidence of relapse and Infectious disease.
12.Anti viral (HTLV-1) effect.
13.Relationship between donor status for HTLV-1 infection (carrier or non-carrier) and anti tumor effect or anti viral effect.
14.Effectiveness and toxicity of donor lymphocyte infusion for mixed chimera.
15.Anti ATL effect of discontinuation of immunosuppressant after relapse of the disease.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Peripheral blood stem cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning 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
50 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria (1) ATL patients whose disease is controlled by the chemotherapy to CR, PR or NC status.
(2) HLA matched related donor.
(3) Patient must fulfill the following criteria; 1.Age is between 50 and 70 years. 2.A patient ranging age 20 to 49 years is eligible if he (she) fulfills one or more criteria of organ dysfunction described bellow (a) to (d). (a) Resting ejection fraction between 50 and 60% by UCG. (b) SaO2 90 to 95% in room air. (c) Serum Cr level between 1.5 mg/dL and 2.0 mg/dL. (d) T.Bil level between 1.5mg/dL and 2.0 mg/dL or GPT over 3 times of upper limit, under 4 times.
(4) ECOG performance status 0 or 1.
(5) Written informed consent from the patient.
(6) Life expectancy beyond 3 months is anticipated by certain treatment.
Key exclusion criteria (1) A patient is uneligible if he (she) has (a) to (d). (a) Resting ejection fraction bellow 50% by UCG. (b) SaO2 bellow 90% in room air. (c) Serum Cr level above 2.0 mg/dL. (d) CCr bellow 20 mL/min/m2. (e) T.Bil level above 2.0 mg/dL or GPT over 4 times of upper limit.
(2) Uncontrollable active infection.
(3) Active CNS lesion at registration.
(4) Woman who is pregnant, possibly pregnant or breast feeding
(5) On or taking major tranquilizer, antidepressant, antimanic.
(6) History of adverse reaction for the agents included in the protocol in conditioning (fludarabine, buslufan), in GVHD prophylaxis (Cyclosporine, steroids) and G-CSF.
(7) Recipient of previous allogeneic hematopoietic stem cell transplantation.
(8) Positive for HIV antibody.
(9) Positive for HBs antigen.
(10) Uncontrollable disease by the chemotherapy.
(11) Have an active cancer.
(12) Patients evident negative monoclonality of HTLV-1 by southern blot analysis.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Okamura
Organization National Hospital Organization Kyushu Cancer Center
Division name Division of Clinical Research
Zip code
Address 3-1-1 Notame Minami-ku Fukuoka-city, Japan
TEL 092-541-3231
Email jyokamur@nk-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ilseung Choi
Organization National Hospital Organization Kyushu Cancer Center
Division name Division of Hematology
Zip code
Address 3-1-1 Notame Minami-ku Fukuoka-city, Japan
TEL 092-541-3231
Homepage URL
Email ilchoi@nk-cc.go.jp

Sponsor
Institute Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan
Institute
Department

Funding Source
Organization Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan.
Organization
Division
Category of Funding Organization Japanese Governmental office
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 九州がんセンター(福岡県)

Other administrative information
Date of disclosure of the study information
2006 Year 05 Month 01 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
2005 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 03 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 11 Month 01 Day
Date analysis concluded
2014 Year 08 Month 10 Day

Other
Other related information

Management information
Registered date
2006 Year 04 Month 24 Day
Last modified on
2018 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000499

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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