UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007569 |
|---|---|
| Receipt number | 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 13:55:27 |
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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
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
fukushin@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University, Faculty of Medicine, Devision of Hematology and Oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008939
