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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007569
Receipt No. R000008939
Scientific Title feasibility and efficacy of chemotherapy combined with zoledronic acid : phase I/II trial for adult T-cell leukemia/lymphoma (ZAAT study)
Date of disclosure of the study information 2012/03/27
Last modified on 2016/10/05

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Basic information
Public title feasibility and efficacy of chemotherapy combined with zoledronic acid : phase I/II trial for adult T-cell leukemia/lymphoma (ZAAT study)
Acronym ZAAT study
Scientific Title feasibility and efficacy of chemotherapy combined with zoledronic acid : phase I/II trial for adult T-cell leukemia/lymphoma (ZAAT study)
Scientific Title:Acronym 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
1st name
Middle name
Last name Shinya Kimura
Organization Saga university, Faculty of Medicine
Division name Hematology and Oncology
Zip code
Address Nabeshima 5-1-1, Saga,Saga
TEL 81-952-34-2366
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noriyasu Fukushima
Organization Saga University, Faculty of Medicine
Division name Hematology and Oncology
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 27 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 Terminated
Date of protocol fixation
2012 Year 01 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000008939

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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