- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03625388
Low Dose Dasatinib (50 mg Daily) as First-line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Amman, Jordan, 11941
- King Hussein Cancer Center (KHCC)
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Amman, Jordan, 11942
- Jordan University Hospital (JUH)
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Beirut, Lebanon
- American University of Beirut Medical Center (AUBMC)
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Riyadh, Saudi Arabia
- The King Faisal Specialist Hospital and Research Centre (KFSH&RC)
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Tunis, Tunisia, 1006
- Aziza Othmana Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years.
- Diagnosis of Ph+ or BCR-ABL positive CML in early CP (i.e. time from diagnosis <12 months). Except for hydroxyurea and/or 1-2 doses of cytarabine (up to 6g/m2 total), patients must have received no or minimal prior therapy, defined as 30 days of prior approved tyrosine kinase inhibitor (TKI).
- Clonal evolution defined as the presence of additional chromosomal abnormalities other than the Ph-chromosome has been historically included as a criterion of accelerated phase (AP). However, patients with clonal evolution as the only criterion of AP have a significantly better prognosis, and when present at diagnosis may not impact the prognosis at all. Thus, patients with clonal evolution and no other criteria for AP will be eligible for this study.
- ECOG performance of 0-2.
- Adequate end organ function defined as the following: total bilirubin <1.5x ULN (unless secondary to Gilbert's disease, in which case it should be <2.5x ULN), SGPT <2.5x ULN, creatinine <1.5x ULN.
- Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital
Exclusion Criteria:
- NYHA cardiac class 3-4 heart disease
Cardiac symptoms - Patients meeting the following criteria are not eligible unless cleared by a cardiologist:
- Uncontrolled angina within 3 months
- Diagnosed or suspected congenital long QT syndrome
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
- Prolonged QTc interval on pre-entry electrocardiogram (>460 msec)
History of significant bleeding disorder unrelated to cancer including:
- Diagnosed congenital bleeding disorders (e.g. Von Willebrand's disease)
- Diagnosed acquired bleeding disorder within one year (e.g. acquired anti-factor VIII antibodies)
- Isolated thrombocytopenia without recurrent bleeding episodes shall be considered eligible for study entry
- Patients with active uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders
Women of pregnancy potential must practice an effective method of birth control, unless otherwise instructed, during the course of the study in a manner such that risk of failure is minimized
- Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy
- Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
- Women must continue birth control for the duration of the study and at least 3 months after the last dose of study drug
Pregnant or breast-feeding women are excluded
a. All WOCBP must have a negative pregnancy test prior to first receiving the study drug. If the pregnancy test is positive, the patient must not receive the study drug and must not be enrolled in the study.
- 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 are excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Dasatinib 50 mg
Dasatinib 50 mg orally once daily
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Film coated tablet contains dasatinib monohydrate
Other Names:
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Other: Dasatinib 100 mg
Dasatinib 100 mg orally once daily
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Film coated tablet contains dasatinib monohydrate
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test
Time Frame: 12 months
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Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1%
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib
Time Frame: 18 months
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Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges
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18 months
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Transformation free survival (TFS) in eligible patients randomized to dasatinib 50 mg or dasatinib 100 mg treatment arms
Time Frame: 18 months
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Transformation free survival was measured from the start of therapy to the date of transformation to accelerated or blastic phases while on therapy or to the date of last follow-up.
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18 months
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Event free survival (EFS)
Time Frame: 18 months
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EFS is measured from the start of treatment to the date of any of the following events : loss of CHR, loss of CCyR or MCyR, dose escalation, discontinuation of therapy for toxicity or lack of efficacy, progression to AP or BP, or death from any cause at any time
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18 months
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Blastic phase (BP) transformation
Time Frame: 18 months
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BP is defined as the presence of 30% blasts or more in the peripheral blood or bone marrow
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18 months
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Overall survival
Time Frame: 18 months
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Overall survival time is defined as the time from date of randomization until the date of death from any cause at any time or date of last follow up
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18 months
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Proportion of patients with Complete cytogenetic response (CCyR) at 12 months
Time Frame: 12 months
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defined as 0% Ph+ metaphases, or FISH ≤2%, or BCR-ABL transcripts (IS) ≤1%
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12 months
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Proportion of patients with MR 4.5 at 18 months
Time Frame: 18 months
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(BCR-ABL transcripts ≤ 0.0032%)
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18 months
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Health-Related Quality of Life (HRQoL): EORTC QOLCML24
Time Frame: 18 months
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Mean change in Health-Related Quality of Life (HRQoL) utilizing EORTC QOLCML24 questionnaire throughout treatment visits
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18 months
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Frequency of not taking the medications as prescribed
Time Frame: 18 months
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Evaluated by identifying the frequency of not taking the medications as prescribed and the reasons.
The decision on non-compliance is based on the treating physician's judgment.
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18 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Disease Attributes
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Chronic Disease
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Dasatinib
Other Study ID Numbers
- LPI-JOR-LEB-KSA-TUN-2017-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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