UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009770 |
|---|---|
| Receipt number | R000011446 |
| Scientific Title | Phase II clinical study of adherence to dasatinib in Japanese patients with de novo chronic phase chronic myeloid leukemia |
| Date of disclosure of the study information | 2013/01/16 |
| Last modified on | 2014/07/23 22:43:44 |
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Basic information
Public title
Phase II clinical study of adherence to dasatinib in Japanese patients with de novo chronic phase chronic myeloid leukemia
Acronym
ADAM 01
(Adherence of DAsatinib towards complete Molecular response 01 study)
Scientific Title
Phase II clinical study of adherence to dasatinib in Japanese patients with de novo chronic phase chronic myeloid leukemia
Scientific Title:Acronym
ADAM 01
(Adherence of DAsatinib towards complete Molecular response 01 study)
Region
| Japan |
Condition
Condition
chronic myeloid leukemia chronic phase
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine an adherence of dasatinib therapy in Japanese patients with de novo chronic phase chronic myeloid leukemia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Assessing medication adherence till 12 months.
Key secondary outcomes
1) Assessment of Medication Possession Ratio (MPR)
2) Assessment of pharmacokinetics of dasatinib at day 14
3) Examine the relationship between blood concentration of dasatinib at day 28 and adverse events
4) Assessment of the therapeutic effect at 1, 3, 6, and 12 months
5) Quantitative analysis of chimeric bcr/abl mRNAs at 3 months
6) Adverse events assessment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) De novo chronic myeloid leukemia patients in chronic phase (Who meet all the conditions listed below)
a) Less than 15% myeloblasts in the bone marrow
b) Less than 30% myeloblasts plus promyelocytes in the bone marrow
c) Less than 20% basophils in the peripheral blood
d) Platelet counts of 100,000 / mm3 or more
e) Absence of extramedullary disease except for hepatosplenomegaly
f) Cells carrying Ph chromosome or its variant confirmed by bone marrow cytogenetics test
2) Patients have an ECOG performance status of 0 to 2
3) Patients with adequate hepatic, renal and pulmonary function
a) AST and ALT less than 5 times the institutional upper limit, with total bilirubin less than 3 times the institutional upper limit
b) Serum creatinine level less than 3 times the institutional upper limit
c) PaO2 greater than 60 mmHg by arterial blood gas analysis, or SpO2 not below than 93% by pulse oximeter, while breathing room air
4) Signed written informed consent
Key exclusion criteria
Patients who meet any of the following criteria are excluded from this study
1) Who have received therapy with anticancer agents other than hydroxycarbamide within the most recent one month
2) Presence of any other active neoplasm
3) Pregnant and lactating woman
4) Presence of apparent pleural effusion
5) Patients with complication or history of serious or poor-controlled cardiovascular disorders as below
a) Cardiac infarction within 6 months
b) Angina pectoris within 3 months
c) Congestive heart failure within 3 months
6) QTc interval prolongation (adjusted according to Fridericia's formula) on the electrocardiogram exceed 450 msec at baseline
7) Patients with previous history or complication that the investigator considered inappropriate to this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohshi Ohishi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Hematology and Oncology
Zip code
Address
2-174 Edobashi, Tsu, Mie
TEL
059-231-5016
koishi@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumihiko Monma |
Organization
Mie University Graduate School of Medicine
Division name
Department of Hematology and Oncology
Zip code
Address
2-174 Edobashi, Tsu, Mie
TEL
059-231-5016
Homepage URL
f-monma@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Hematology and Oncology, Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Hematology and Oncology, Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
三重大学大学院医学系研究科（三重県）
三重大学医学部附属病院（三重県）
三重県厚生農業協同組合連合会鈴鹿中央総合病院（三重県）
日本赤十字社伊勢赤十字病院（三重県）
社会医療法人峰和会鈴鹿回生病院（三重県）
三重厚生農業協同組合連合会松阪中央総合病院（三重県）
市立四日市病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 16 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2013 | Year | 01 | Month | 13 | Day |
Last modified on
| 2014 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011446
| Research Plan | |
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| Registered date | File name |
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