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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001355
Receipt No. R000001649
Scientific Title A phase I trial of unrelated bone marrow transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen.
Date of disclosure of the study information 2008/09/08
Last modified on 2018/09/12

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Basic information
Public title A phase I trial of unrelated bone marrow transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen.
Acronym A phase I trial of unrelated bone marrow transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen. (ATL-NST-4)
Scientific Title A phase I trial of unrelated bone marrow transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen.
Scientific Title:Acronym A phase I trial of unrelated bone marrow transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen. (ATL-NST-4)
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 of unrelated bone marrow transplantation for Lymphoma type or acute type of adult T cell leukemia/lymphoma following reduced intensity conditioning regimen.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Survival after transplantation at day 100 and achievement of complete chimera after transplantation before day 100.
Key secondary outcomes 1)Over all survival
2)Disease free survival
3)Anti leukemia/lymphoma effect
4)Anti viral(HTLV-1) effect
5)Incidence and severity of GVHD
6)Other adverse event

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 Unrelated bone marrow 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
65 years-old >=
Gender Male and Female
Key inclusion criteria (1) Acute or lymphoma type ATL patients.
(2) No suitable 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) Written informed consent from the patient.
(5)ATL patients whose disease is controlled by the chemotherapy to CR or PR.
(6) ECOG performance status 0 or 1.
(7) 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) Have an active cancer.
Target sample size 15

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 北海道大学血液内科(北海道)
札幌北楡病院(北海道)
国立がんセンター中央病院(東京都)
名古屋市立大学臨床分子内科学(愛知県)
名古屋第一赤十字病院(愛知県)
京都府立医大血液腫瘍内科(京都府)
大阪市立大学(大阪府)
愛媛県立中央病院血液内科(愛媛県)
高知大学医学部 第三内科(高知県)
浜の町病院血液病科(福岡県)
九州大学病院遺伝子細胞療法部(福岡県)
九州大学第三内科(福岡県)
長崎大学原研内科(長崎県)
熊本医療センター血液内科(熊本県)
大分大学医学部(大分県)
今村病院分院血液内科(鹿児島県)
九州がんセンター血液内科(福岡県)

Other administrative information
Date of disclosure of the study information
2008 Year 09 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

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 05 Month 15 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2013 Year 08 Month 01 Day
Date of closure to data entry
2014 Year 08 Month 01 Day
Date trial data considered complete
2014 Year 08 Month 01 Day
Date analysis concluded
2015 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 09 Month 03 Day
Last modified on
2018 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001649

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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