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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024548
Receipt No. R000028252
Scientific Title A Multicenter Joint Phase II Clinical Study to Evaluate the Efficacy and Safety of Dasatinib Very Low Dose Therapy in Elderly Patients with Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia
Date of disclosure of the study information 2016/11/01
Last modified on 2016/10/24

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Basic information
Public title A Multicenter Joint Phase II Clinical Study to Evaluate the Efficacy and Safety of Dasatinib Very Low Dose Therapy in Elderly Patients with Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia
Acronym Dasatinib very low dose for elderly CML patients (DAVLEC)
Scientific Title A Multicenter Joint Phase II Clinical Study to Evaluate the Efficacy and Safety of Dasatinib Very Low Dose Therapy in Elderly Patients with Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia
Scientific Title:Acronym Dasatinib very low dose for elderly CML patients (DAVLEC)
Region
Japan

Condition
Condition chronic-phase chronic myeloid leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of the study is to evaluate the efficacy and safety of personalized medicine with dasatinib by setting the initial dose at a very low dose (20 mg/day) and adjusting and optimizing the dose using the treatment effects and adverse events (AEs) as indicators in elderly patients (aged 70 years or older) with newly diagnosed chronic-phase chronic myeloid leukemia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Major molecular response (MMR) achievement rate at 12 months after initiation of treatment
Key secondary outcomes [1]Deep molecular response (DMR: MR4, MR4.5) achievement rate at 12 months after initiation of treatment
[2]Incidences of AEs of all grades or grade 3 or 4
[3]Treatment discontinuation rate due to AEs after 12 months of treatment with the drug
[4]Treatment discontinuation rate due to progression of the disease condition or treatment failure (Failure) after 12 months of treatment
[5]Association of Sokal score, Hasford score, and EUTOS score with treatment effects
[6]Association of BCR-ABL1 halving time with treatment effects at 3 months after initiation of treatment
[7]Association of blood concentration of dasatinib with treatment effects and AEs
[8]Association of peripheral blood T and NK cell profiles with treatment effects and AEs

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Once-daily oral administration of dasatinib will be started at the dose of 20 mg. The treatment effect will be evaluated according to the European LeukemiaNet recommendations (ELN2013) at 3, 6, 9 and 12 months after initiation of treatment. Since ELN2013 does not stipulate the standards for 9 months after initiation of treatment, the standards at 6 months after initiation of treatment will be followed.
1) Treatment will be continued without changing the dose in case the effect is evaluated as optimal response and all AEs are of grade 2 or milder.
2) The daily dose of dasatinib will be increased by 20 mg in case the effect is evaluated as Warning and all AEs are of grade 2 or milder. However, if the dose has been reduced because of AEs of grade 3 or severer, treatment will be continued at the same dose without increasing the dose.
3) The protocol treatment will be discontinued and more appropriate treatment will be provided at the discretion of the attending physician in case the effect is evaluated as Failure, including progression of the disease stage into the accelerated phase or acute phase.
4) Administration of dasatinib will be suspended in case hematological toxicity of grade 3 or severer (neutrophil count less than 1,000/micro L or platelet count less than50,000/micro L) or nonhematological toxicity of grade 3 or severer are observed during all treatment periods. Treatment will be resumed after recovery from toxicity by reducing the daily dose of dasatinib by 20 mg. In case dasatinib is administered at the daily dose of 20 mg, the frequency of administration will be reduced to alternate-day administration of 20 mg. In case the above AEs are observed even with alternate-day administration of dasatinib at 20 mg/day, the protocol treatment will be discontinued, and more appropriate treatment will be provided at the discretion of the attending physician.

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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Newly diagnosed chronic-phase chronic myeloid leukemia (CP-CML). The European LeukemiaNet (ELN) will be followed when evaluating the disease stage (Table 1).
2) Patients aged 70 years or older at the time fo enrollment
3) Patients with ECOG performance status of 0 to 2
4) Patients whose primary organ (liver, kidneys and lungs) functions are maintained (each institutional standard values)
5) Patients who have given written informed consent (approval of the guardian will be required in the case the subject is a minor)
Key exclusion criteria 1)Patients with a history of treatment with drugs (imatinib, nilotinib, dasatinib, and interferon) for CML. Patients who have received prior treatment with Hydrea within 4 weeks can be enrolled.
2)Patients with a history of the following significant or uncontrollable cardiovascular disorders or their complications
2.1)Patients with obvious pleural effusion
2.2) Patients with a history of myocardial infarction within 6 months
2.3) Patients with a history of angina pectoris within 3 months
2.4) Patients with a history of congestive cardiac failure within 3 months
2.5) Patients with suspected congenital QT prolongation syndrome
2.6) Patients with QTc interval prolongation by 500 msec or more on 12-lead ECG
3)Patients receiving treatment for malignant disorders other than CML
4)Patients with uncontrollable severe disease history or complications
5)Patients with a history of hypersensitivity to dasatinib
6)Other patients who are deemed to be ineligible for the study by the attending physician
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinya Kimura
Organization Saga University
Division name Hematology, Respiratory Medicine and Oncology
Zip code
Address 5-1-1 Nabeshima Saga, Saga
TEL 0952-34-2353
Email shkimu@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kensuke Kojima
Organization Saga University
Division name Hematology, Respiratory Medicine and Oncology
Zip code
Address 5-1-1 Nabeshima Saga, Saga
TEL 0952-34-2366
Homepage URL http://www.saga-hor.jp/main/
Email kkojima@cc.saga-u.ac.jp

Sponsor
Institute NPO Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department

Funding Source
Organization Bristol-Myers Squibb Co. Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 佐賀大学医学部附属病院(佐賀県)、北海道大学病院(北海道)福島県立医科大学(福島県)、秋田大学病院(秋田県)、東京慈恵医科大学附属 柏病院

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 01 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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2018 Year 10 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 01 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

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


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028252

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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