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

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 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


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

Value
https://center6.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