Chronic Myelogenous LeukemiaPhase 2NCT03625388
Low Dose Dasatinib (50 mg Daily) as First-line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia
A Phase 2 study testing Dasatinib in people with Chronic Myelogenous Leukemia, run by Hikma Pharmaceuticals LLC at 5 sites in 4 countries.
Trial summary
The purpose of this multicenter randomized study is to compare efficacy and safety of dasatinib 50 mg once daily and dasatinib 100 mg once daily in patients with early chronic phase (CP) chronic myeloid leukemia (CML) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myelogenous Leukemia
- What is being tested?
- Dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 5 Nov 2018to 22 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
- 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.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Jordan2 sites
King Hussein Cancer Center (KHCC)
Amman, 11941
Jordan University Hospital (JUH)
Amman, 11942
Saudi Arabia1 site
The King Faisal Specialist Hospital and Research Centre (KFSH&RC)
Riyadh
About this study
Official 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
The purpose of this multicenter randomized study is to compare efficacy and safety of dasatinib 50 mg once daily and dasatinib 100 mg once daily in patients with early chronic phase (CP) chronic myeloid leukemia (CML)
Read the detailed description
A multicenter, prospective, open-label, randomized Phase II study to compare efficacy by measuring rates of major molecular response (MMR) at 12 months in patients with Ph+ chronic phase (CP) chronic myeloid leukemia (CML) randomized to receive either dasatinib 50 mg QD or dasatinib 100 mg QD. Approximately 100 patients are expected to be randomized. The duration of patient participation will be 18 months
- Conditions
- Chronic Myelogenous Leukemia
- Being tested
- Dasatinib
- Keywords
- Leukemia, Myeloid, Philadelphia Positive, Dasatinib, Generic Dasatinib, Dasatinib 50 mg once daily, Early chronic phase chronic myeloid leukemia
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called Elpida®
Film coated tablet contains dasatinib monohydrate
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib 50 mg | Other | Dasatinib 50 mg orally once daily Receives: Drug: Dasatinib |
| Dasatinib 100 mg | Other | Dasatinib 100 mg orally once daily Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test
Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1%
Measured: 12 months
Secondary outcomes (9)
Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib
Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges
Measured: 18 months
Transformation free survival (TFS) in eligible patients randomized to dasatinib 50 mg or dasatinib 100 mg treatment arms
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.
Measured: 18 months
Event free survival (EFS)
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
Measured: 18 months
Blastic phase (BP) transformation
BP is defined as the presence of 30% blasts or more in the peripheral blood or bone marrow
Measured: 18 months
Overall survival
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
Measured: 18 months
Proportion of patients with Complete cytogenetic response (CCyR) at 12 months
defined as 0% Ph+ metaphases, or FISH ≤2%, or BCR-ABL transcripts (IS) ≤1%
Measured: 12 months
Proportion of patients with MR 4.5 at 18 months
(BCR-ABL transcripts ≤ 0.0032%)
Measured: 18 months
Health-Related Quality of Life (HRQoL): EORTC QOLCML24
Mean change in Health-Related Quality of Life (HRQoL) utilizing EORTC QOLCML24 questionnaire throughout treatment visits
Measured: 18 months
Frequency of not taking the medications as prescribed
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start5 Nov 2018
- Primary completion22 Jul 2023
- Study completion22 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be randomized to receive either dasatinib 50 mg or dasatinib 100 mg orally once daily for the duration of the study which is 18 months.
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hikma Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625388
- Sponsor's protocol ID
- LPI-JOR-LEB-KSA-TUN-2017-01
- Status last verified
- Sep 2023
- First submitted
- 2 Aug 2018
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03625388
- Acronym / sponsor ID
- LPI-JOR-LEB-KSA-TUN-2017-01
- Conditions
- Chronic Myelogenous Leukemia
- Keywords
- Leukemia, Myeloid, Philadelphia Positive, Dasatinib, Generic Dasatinib, Dasatinib 50 mg once daily, Early chronic phase chronic myeloid leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hikma Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 22 Jul 2023 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this multicenter randomized study is to compare efficacy and safety of dasatinib 50 mg once daily and dasatinib 100 mg once daily in patients with early chronic phase (CP) chronic myeloid leukemia (CML)
Detailed description
A multicenter, prospective, open-label, randomized Phase II study to compare efficacy by measuring rates of major molecular response (MMR) at 12 months in patients with Ph+ chronic phase (CP) chronic myeloid leukemia (CML) randomized to receive either dasatinib 50 mg QD or dasatinib 100 mg QD. Approximately 100 patients are expected to be randomized. The duration of patient participation will be 18 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients will be randomized to receive either dasatinib 50 mg or dasatinib 100 mg orally once daily for the duration of the study which is 18 months.
| Arm | Type | Receives |
|---|---|---|
| Dasatinib 50 mg | Other | Drug: DasatinibDasatinib 50 mg orally once daily |
| Dasatinib 100 mg | Other | Drug: DasatinibDasatinib 100 mg orally once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- NYHA cardiac class 3-4 heart disease
- Cardiac symptoms - Patients meeting the following criteria are not eligible unless cleared by a cardiologist:
- History of significant bleeding disorder unrelated to cancer including:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasatinibAlso: Elpida®Film coated tablet contains dasatinib monohydrate | Drug | Dasatinib 100 mg, Dasatinib 50 mg |
Primary outcome
Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test
Time frame: 12 months
Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1%
9 secondary outcomes
Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib
Time frame: 18 months
Transformation free survival (TFS) in eligible patients randomized to dasatinib 50 mg or dasatinib 100 mg treatment arms
Time frame: 18 months
Event free survival (EFS)
Time frame: 18 months
Blastic phase (BP) transformation
Time frame: 18 months
Overall survival
Time frame: 18 months
Proportion of patients with Complete cytogenetic response (CCyR) at 12 months
Time frame: 12 months
Proportion of patients with MR 4.5 at 18 months
Time frame: 18 months
Health-Related Quality of Life (HRQoL): EORTC QOLCML24
Time frame: 18 months
Frequency of not taking the medications as prescribed
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib in people with Chronic Myelogenous Leukemia, run by Hikma Pharmaceuticals LLC at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Jordan, Lebanon, Saudi Arabia, Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.