UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A feasibility trial of cord blood cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen
Title of the study (Brief title)	A feasibility trial of cord blood cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen (ATL-NST-5)
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 cord blood cell 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	Not applicable

Assessment
Primary outcomes	Survival after transplantation at day 100 and achievement of engraftment 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	Cord blood 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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Acute or lymphoma type ATL patients. (2) No suitable related donor, or no suitable unrelated bone marrow 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)ATL patients whose disease is controlled by the chemotherapy to CR or PR. (5) ECOG performance status 0 or 1. (6) Life expectancy beyond 3 months is anticipated by certain treatment. (7)Written informed consent from the patient. (8)Present of suitable single unit cord blood
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, melphalan), in GVHD prophylaxis (tacrorimus, MMF, 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	Naokuni Uike
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
Email	nuike@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	Ministry of Health, Welfare, and Labor of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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） 国立がん研究センター中央病院（東京都） 虎の門病院血液科（東京都） 東海大学医学部　血液腫瘍内科（神奈川県） 京都大学血液内科（京都府） 大阪市立大学血液内科（大阪府） 九州大学病院血液腫瘍内科（福岡県） 浜の町病院血液病科（福岡県） 久留米大学血液腫瘍内科（福岡県） 佐賀大学血液内科（佐賀県） 熊本医療センター血液内科（熊本県） 長崎大学原研内科（長崎県） 佐世保市立総合病院血液内科（長崎県） 大分大学病院血液内科（大分県） 大分県立病院血液内科（大分県） 今村病院分院血液内科（鹿児島県） 鹿児島大学病院　血液膠原病内科（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	2012 Year 05 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 30 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2014 Year 04 Month 01 Day
Date of closure to data entry	2016 Year 04 Month 01 Day
Date trial data considered complete	2016 Year 10 Month 01 Day
Date analysis concluded	2016 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 05 Month 10 Day
Last modified on	2018 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009332