DasatinibPhase 4NCT04155411
Dose Reduced Dasatinib (70 mg Daily) as First-line Treatment for Newly Diagnosed CML-CP
A Phase 4 study testing Dasatinib in people with Dasatinib and BCR-ABL, run by Shenzhen Second People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to explore the efficacy and safety of dasatinib 70 mg once daily as first line therapy in patients with early chronic phase (CP) chronic myeloid leukemia (CML). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dasatinib, BCR-ABL, Chronic Myeloid 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
- 65 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 1 Dec 2023
- Phase
- Phase 4
- 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 to 70 years
- 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-CP within 6 months.
- ECOG performance of 0-2.
- Adequate end organ function defined as the following: total bilirubin <1.5x 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
- History of any TKI treatments.
- History of Pulmonary arterial hypertension and Pleural effusion
- 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 12 months.
- Diagnosed or suspected congenital long QT syndrome.
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- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes).
- Prolonged QTc interval on pre-entry electrocardiogram (>450 msec).
- 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.
- Pregnant or breast-feeding women are excluded.
- 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
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xin Du
Shenzhen, Guangdong, 518000
Xin Du, PHD
About this study
Official title: Efficacy and Safety of Dasatinib 70 mg as First-Line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia (CML-CP)
The purpose of this study is to explore the efficacy and safety of dasatinib 70 mg once daily as first line therapy in patients with early chronic phase (CP) chronic myeloid leukemia (CML).
Read the detailed description
A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of 70mg dasatinib by measuring rates of major molecular response (MMR) at 12 months in patients with CML-CP in China. Approximately 65 Patients will be recruited consecutively from the study sites during the enrollment period and will be given dasatinib 70 mg QD. The duration of patient participation will be 12 months.
- Conditions
- Dasatinib, BCR-ABL, Chronic Myeloid Leukemia
- Being tested
- Dasatinib
- Keywords
- Dasatinib, CML-CP
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
70 mg of Dasatinib orally daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib 70 mg | Experimental | Not described 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 (4)
Proportion of patients with MR 4.0 at 12 months.
Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01%
Measured: 12 months
Proportion of patients with MR 4.5 at 12 months.
Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032%
Measured: 12 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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start1 Dec 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DasatinibStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155411
- Sponsor's protocol ID
- 20191103
- Status last verified
- Jun 2022
- First submitted
- 5 Nov 2019
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dasatinib 70 mg as First-Line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia (CML-CP)
- ClinicalTrials.gov ID
- NCT04155411
- Acronym / sponsor ID
- 20191103
- Conditions
- Dasatinib, BCR-ABL, Chronic Myeloid Leukemia
- Keywords
- Dasatinib, CML-CP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 7 Nov 2019 (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 study is to explore the efficacy and safety of dasatinib 70 mg once daily as first line therapy in patients with early chronic phase (CP) chronic myeloid leukemia (CML).
Detailed description
A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of 70mg dasatinib by measuring rates of major molecular response (MMR) at 12 months in patients with CML-CP in China. Approximately 65 Patients will be recruited consecutively from the study sites during the enrollment period and will be given dasatinib 70 mg QD. The duration of patient participation will be 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dasatinib 70 mg | Experimental | Drug: Dasatinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Diagnosis of Ph+ or BCR-ABL positive CML-CP within 6 months.
- ECOG performance of 0-2.
- Adequate end organ function defined as the following: total bilirubin <1.5x 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
Key exclusion criteria (12 listed)
- History of any TKI treatments.
- History of Pulmonary arterial hypertension and Pleural effusion
- 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 12 months.
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 |
|---|---|---|
| Dasatinib70 mg of Dasatinib orally daily for 12 months | Drug | Dasatinib 70 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%
4 secondary outcomes
Proportion of patients with MR 4.0 at 12 months.
Time frame: 12 months
Proportion of patients with MR 4.5 at 12 months.
Time frame: 12 months
Proportion of patients with Complete cytogenetic response (CCyR) at 12 months
Time frame: 12 months
Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dasatinib in people with Dasatinib and BCR-ABL, run by Shenzhen Second People's Hospital at 1 site in China.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Du (075583366388, duxingz@medmail.com.cn), or a site near the patient. 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 27 Jul 2022.