UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000409 |
|---|---|
| Receipt number | 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 23:07:27 |
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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
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
ilchoi@nk-cc.go.jp
Sponsor or person
Institute
Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000499
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