UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	feasibility and efficacy of chemotherapy combined with zoledronic acid : phase I/II trial for adult T-cell leukemia/lymphoma (ZAAT study)
Title of the study (Brief title)	ZAAT study
Region	Japan

Condition
Condition	Adult T-cell leukemia/lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the feasibility and efficacy of chemotherapy combined zoledronic acid for ATL
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	progression free survival in one year
Key secondary outcomes	progression free hypercalcemia, overall suvival in one year, feasibility for scheduled zoledronic acid

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
Interventions/Control_1	Treatment of zoledronic acid
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	15 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	a) Confirmation of T-cell with hematological or pathological examination b) positive for anti HTLV-1 antibody c) Acute type, lymphoma type or transformed to acute or lymphoma type from chronic or smoldering type d) Aged 15 to 75 years old e) perfomance status 0-3, PS 4 caused by hypercalcemia is eligible f) No prior chemotherapy or radiotherapy for ATL, except for steroid g) No central nervus system involvement at diagnosis h) Sufficient function of main organ i) No the need for invasive dental treatment j) Written informed consent from a patient. If consciousness disturbance caused by hypercalcemia, it allowed to the acceptance of family
Key exclusion criteria	a)History of glaucome b) Uncontrollable diabetes mellitus or administration of insulin c) Uncontrollable hypertension d) Poor cardiac function e) Active infection requiring systemic therapy f) acute hepatitis, chronic hepatitis, liver cirrhosis g) Synchronous or metachronous maliganacy h) Psychological problem i) active dental disease indicating invasive dental treatment j) Systemic steroid treatment k) History of adminisration of intravenous bisphophonate
Target sample size	21

Research contact person
Name of lead principal investigator	Shinya Kimura
Organization	Saga university, Faculty of Medicine
Division name	Hematology and Oncology
Address	Nabeshima 5-1-1, Saga,Saga
TEL	81-952-34-2366
Email

Public contact
Name of contact person	Noriyasu Fukushima
Organization	Saga University, Faculty of Medicine
Division name	Hematology and Oncology
Address
TEL
Homepage URL
Email	fukushin@cc.saga-u.ac.jp

Sponsor
Institute	Saga University, Faculty of Medicine, Devision of Hematology and Oncology
Institute
Department

Funding Source
Organization	Saga University, Faculty of Medicine, Devision of Hematology and Oncology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Karatsu red-cross hospiral
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

Other administrative information
Date of disclosure of the study information	2012 Year 03 Month 27 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 01 Month 01 Day
Anticipated trial start date	2012 Year 03 Month 01 Day
Last follow-up date	2016 Year 10 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2012 Year 03 Month 24 Day
Last modified on	2016 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008939