UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I trial of unrelated bone marrow transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen.
Title of the study (Brief title)	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	Jun Okamura
Organization	National Hospital Organization Kyushu Cancer Center
Division name	Division of Clinical Research
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	Ilseung Choi
Organization	National Hospital Organization Kyushu Cancer Center
Division name	Division of Hematology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 05 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000001649