UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024548 |
|---|---|
| Receipt number | 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 | 2024/03/29 15:32:18 |
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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
50
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
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/
kkojima@cc.saga-u.ac.jp
Sponsor or person
Institute
NPO Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 13 | Day |
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
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028252
