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Trial details
Trial details
Randomized, Open-Label, Phase II, Multicenter, Multi-Country Study to Evaluate Safety and Efficacy of Dasatinib 50 mg in First-Line Treatment of Early Chronic Phase Chronic Myeloid Leukemia
Current status:
Approved
|
Date registered:
29/06/2021
|
Date last updated:
24/06/2021
Trial version(s)
History: 24/10/2018
History: 24/10/2018
History: 24/10/2018
Current: 24/10/2018
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2019010169
Protocol number
LPI-JOR-LEB-KSA-TUN-2017-01
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
05/11/2018
Primary sponsor
Hikma Pharmaceuticals
Primary sponsor: Country of origin
Jordan
Public title
Randomized, Open-Label, Phase II, Multicenter, Multi-Country Study to Evaluate Safety and Efficacy of Dasatinib 50 mg in First-Line Treatment of Early Chronic Phase Chronic Myeloid Leukemia
Acronym
NA
Scientific title
Randomized, Open-Label, Phase II, Multicenter, Multi-Country Study to Evaluate Safety and Efficacy of Dasatinib 50 mg in First-Line Treatment of Early Chronic Phase Chronic Myeloid Leukemia
Acronym
NA
Brief summary of the study: English
The primary endpoint to be measured during the study is the proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test. The study will be a multicenter, prospective, open-label, randomized Phase II study with a parallel design. Eligible patients with Ph+ CP CML will be randomly assigned to receive either dasatinib 50 mg QD or dasatinib 100 mg QD. The duration of patient participation will be 18 months.
Brief summary of the study: Arabic
الهدف الأساسي من الدراسة هو قياس نسبة المرضى الذين يحققون استجابة (MMR)جزيئية كبرى (RQ-PCR)ويحافظون عليها خلال 12 شهرًا باستخدام اختبار تفاعل سلسلة البوليميراز الكمي اللحظي في المرضى المؤهلين الذين يعانون من سرطان الدم النقوي المزمن الذي يحتوي على الكروموسوم فيلادلفيا- إيجابي في المرحلة المزمنة وتم توزيعهم بشكل عشوائي في مجموعات العلاج لتلقي جرعة يومية من دواء دازاتينيب تبلغ 50 ملغم (يتم تناولها في هيئة قرص واحد 50 ملغم مرة واحدة يوميًا) أو جرعة يومية (من دواء دازاتينيب تبلغ 100 ملغم (يتم تناولها في هيئة قرصين بحجم 50 ملغم مرَّة واحدة يوميًا. .دراسة عشوائية، مفتوحة التسمية، من المرحلة الثانية، متعددة المراكز في دول متعددة ستكون مدة المشاركة 18 شهرًا
Health conditions/problem studied: Specify
Early Chronic Phase Chronic Myeloid Leukemia
Interventions: Specify
dasatinib 50 mg QD or dasatinib 100 mg QD
Key inclusion and exclusion criteria: Inclusion criteria
Age ≥ 18 years. Diagnosis of Ph+ or BCR-ABL positive CML in early CP (i.e. time from diagnosis <12 months). Clonal evolution ECOG performance of 0-2. Adequate end organ function
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
100
Key inclusion and exclusion criteria: Exclusion criteria
NYHA cardiac class 3-4 heart disease Cardiac symptoms History of significant bleeding disorder Patients with active uncontrolled psychiatric disorders Pregnant or breast-feeding women Patients in late chronic phase (i.e. time from diagnosis to treatment >12 months), accelerated phase (except as noted in inclusion criteria 2) or blast phase
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Dose comparison
Study phase
1
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
No
Name of IMP
Dasatinib
Type of IMP
Others
Type of IMP: Specify
chemical
Pharmaceutical class
Tyrosine Kinase Inhibitor
Therapeutic indication
early chronic CML
Therapeutic benefit
Reduce the rate of adverse events and decrease cost of medications with the dose 50 mg while maintaining the efficacy. enhance treatment compliance
Biospecimen retention
None retained
Biospecimen description
NONE
Target sample size
100
Actual enrollment target size
100
Date of first enrollment: Type
Actual
Date of first enrollment: Date
07/03/2019
Date of study closure: Type
Actual
Date of study closure: Date
30/06/2022
Recruitment status
Recruiting
Date of completion
30/06/2022
IPD sharing statement plan
No
IPD sharing statement description
NONE
Additional data URL
NA
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Jordan Food and drug administration JFDA
2/1/8/44334
Sources of Monetary or Material Support
Name
Hikma Pharmaceuticals
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Zeina
Ayoub
Ramlet El Bayda
Lebanon
76898970
zayoub@hikma.com
Hikma Pharmaceuticals
Scientific
Ruba
Jaber
Amman
Jordan
00962797486999
rjaber@hikma.com
Hikma Pharmaceuticals
Public
Ali
Bazarbachi
AUBMC
Lebanon
03612434
bazarbac@aub.edu.lb
AUBMC
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
AUBMC
Ali Bazarbachi
Oncologist
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
07/12/2018
Fuad Ziyadeh
irb@aub.edu.lb
01350000
American University of Beirut Medical Center
renewal
29/07/2019
Fuad Ziyadeh
irb@aub.edu.lb
01350000
American University of Beirut Medical Center
protocol amendment
04/06/2021
Deborah Mukherji
irb@aub.edu.lb
01350000
Countries of Recruitment
Name
Jordan
Tunisia
Saudi Arabia
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Chronic Myeloid leukemia
Leukaemia of unspecified cell type (C95)
C95
Interventions
Intervention
Description
Keyword
Elpida
Dasatinib as monohydrate
DAS
Primary Outcomes
Name
Time points
Measure
major molecular response (MMR)
at 12 months
Real-Time Quantitative Polymerase Chain Reaction (RQ-PCR) test
Key Secondary Outcomes
Name
Time points
Measure
safety and tolerability of dasatinib
W2,M1,M2,M3,M6,M9,M12,M18
number, type, severity and frequency of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges.
Transformation free survival (TFS)
Baseline,M3,M6,M9,M12,M18
FISH, PCR
Event free survival (EFS)
Baseline,M3,M6,M9,M12,M18
FISH, PCR
Blastic phase (BP) transformation
Baseline,M3,M6,M9,M12,M18
FISH, PCR
Overall survival (OS)
at study end
% of survived patients
Complete cytogenetic response (CCyR) at 12 months
M12
FISH test
Complete molecular response (CMR) at 18 months
M18
PCR
changes in health-related quality of life (HRQOL)
baseline, M6, M12, M18
EORTC QLQ-CML24 questionnaire
treatment compliance
W2,M1,M2,M3,M6,M9,M12,M18
Checking the medication
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Study progress report 2
26/10/2020
Protocol amendment - Version No.: 2.0 (Final) including Amendment 1
24/06/2021
IRB approval on protocol amendment 1
24/06/2021
Adding SAE Multiorgane failure - initial report
24/06/2021
Adding SAE Multiorgane failure -- follow up report
24/06/2021
Adding SAE change in mental status, seizure - follow up report
24/06/2021
Download as PDF
Save a PDF copy of the summary of the trial