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Chronic Myelogenous Leukemia - Chronic PhasePhase 4NCT04925141

A Study of Dasatinib as First-line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia (CML-CP)

A Phase 4 study testing Dasatinib Tablets in people with Chronic Myelogenous Leukemia - Chronic Phase, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this multicenter,open, prospective and single arm study is to evaluate the efficacy and safety of domestic dasatinib in the first-line treatment of newly diagnosed CML-CP. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dasatinib Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
4 sitesChina
Study dates
10 May 2016to 6 Dec 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥ 18 years and gender is not limited.
  • The chronic-phased CML subjects with Ph + were definitely diagnosed within 6 months before the first use of the study drug. The diagnostic criteria refer to the 2016 edition of Chinese CML diagnosis and treatment guidelines.
  • The Eastern Cooperative Oncology Group (ECOG) performance of 0-2.
  • The function of main organs such as liver and kidney is normal, which shows that serum bilirubin is less than or equal to 1.5 × ULN； Serum ALT and AST ≤ 2.5 × ULN； Serum Cr ≤ 1.5 × ULN； Serum amylase and lipase ≤ 1.5 × ULN; Blood potassium, magnesium, phosphorus and total calcium were more than or equal to the lower limit of normal value, or were corrected to normal range before administration.
  • The subjects voluntarily participate in and signed the informed consent form (ICF), and the process of signing the ICF meet the requirements of the "Practice for quality management of drug clinical trials".

Who cannot join

  • Subjects who have received any TKI treatment in the past.
  • Subjects who have received or are receiving anti CML chemotherapy drugs (except hydroxyurea).
  • Subjects who have received major surgery or no recovery from previous surgery within 4 weeks (including 4 weeks) before the first use of the study drug.
  • Subjects with mental illness, including epilepsy, dementia, severe depression, mania, etc.
  • Subjects with a history of significant congenital or acquired hemorrhagic disease unrelated to CML.
  • Disease history and comorbidities: a) uncontrolled severe disease or active infection that impairs the subject's ability to receive the treatment; b) Uncontrolled or major cardiovascular disease; c) Pulmonary hypertension; d) Subjects with pleural effusion or pericardial effusion of any grade are excluded when screening; when entering the study, subjects with remission of pleural / pericardial effusion of any grade previously diagnosed were allowed to participate in the study.
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  • Subjects with gastrointestinal dysfunction or gastrointestinal diseases that may significantly affect the absorption of the test drug, such as ulcers, uncontrollable nausea, vomiting, diarrhea, malabsorption syndrome, after a small bowel resection, etc.
  • Cardiac dysfunction, including: a) complete left bundle branch block; b) Long QT syndrome, or known family history of long QT syndrome; c) Ventricular or atrial tachyarrhythmia of clinical significance; d) Clinically significant resting bradycardia (< 50 beats per minute); e) QTc>450msec； f) History of clinically confirmed myocardial infarction in the past 12 months; g) History of unstable angina in the past 12 months; h) Other clinicallysignificant heart diseases (e.g., congestive heart failure, etc.).
  • Combined with other primary malignant tumors (except basal cell carcinoma of skin).
  • Subjects who are receiving treatment with strong CYP3A4 inhibitors (e.g., erythromycin Ethylsuccinate, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, imipradil, etc.) and cannot discontinue or switch to other drugs before starting the study drug.
  • Subjects who are receiving strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, Hypericum perforatum, etc.) and the treatment cannot be stopped or replaced by other drugs before starting the study drug.
  • Subjectswho are receiving the treatment of drugs that may prolong QT interval, and the treatment can not be stopped or replaced by other drugs before starting to use the study drug.
  • Previous history of acute (within 1 year before inclusion) or chronic pancreatitis.
  • Known or suspected to be allergic to this kind of drug.
  • Female and male subjects of childbearing age who cannot use adequate methods of contraception , including pregnant or lactating women.
  • Subjects who are receiving the treatment of other test drugs or participated in the clinical trial of other drugs within one month.
  • -

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • The First Affiliated Hospital, Medical College , Zhejiang University

    Hangzhou, Zhejiang, 310013

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

  • The Second People's Hospital of Shenzhen

    Shenzhen, Guangdong, 518035

  • Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: Efficacy and Safety of Dasatinib in the First-line Treatment of Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia (CML-CP)

The purpose of this multicenter,open, prospective and single arm study is to evaluate the efficacy and safety of domestic dasatinib in the first-line treatment of newly diagnosed CML-CP.

Being tested
Dasatinib Tablets
Medical subject headings
Leukemia, Myeloid, Chronic-Phase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dasatinib TabletsDrug

    Tyrosine Kinase Inhibitor (TKI)

Study groups in NCT04925141
Study groupRoleWhat they receive
Dasatinib tabletsExperimentalDasatinib tablets 100 mg orally once daily
Receives: Drug: Dasatinib Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects who achieve and maintain major molecular response (MMR) at 12 months

    MMR is defined as BCR-ABL1IS ≤ 0.1%

    Measured: up to 12 months

Secondary outcomes (11)

  1. Proportion of subjects who achieve and maintain MMR at 3，6 and 18 months

    MMR is defined as BCR-ABL1IS ≤ 0.1%

    Measured: up to 18 months

  2. Time to MMR Overall

    The time to MMR for all participants is defined as the time from first use of the study drug until measurement criteria are first met for MMR.

    Measured: up to 24 months

  3. Cumulative MMR rates at 6, 12 and 24 months

    MMR is defined as BCR-ABL1IS ≤ 0.1%

    Measured: up to 24 months

  4. Proportion of subjects who achieve and maintain MR4.0 and MR4.5 at 6, 12 and 24 months

    MR4.0 is defined as BCR-ABL1IS ≤ 0.01%, MR4.5 is defined as BCR-ABL1IS ≤ 0.0032%

    Measured: up to 24 months

  5. Cumulative complete cytogenic response (CCyR) rates at 12 and 24 months

    CCyR is defined as 0% Ph+ metaphases

    Measured: up to 24 months

  6. Proportion of subjects who achieve and maintain complete hematological response (CHR) at 3 months

    CHR was defined as peripheral blood WBC < 10x109 / L, PLT < 450x109 / L, no immature granulocytes, basophils < 0.05, no symptoms and signs of CML, spleen untouchable

    Measured: up to 3 months

  7. Time to accelerated phase (AP ) / blast crisis (BC)

    Time to AP / BC is defined as the time from the first use of the study drug to the date of CML related death or progression to AP or BC, whichever occurs first. For subjects without these events, the event was truncated at the date of the last evaluation (Hematology, extramedullary disease, or cytogenetic evaluation)

    Measured: up to 24 months

  8. Progression-free Survival (PFS)

    PFS is defined as the time from the first use of the study drug to the earliest occurrence of the following events: death from any cause (if death was the main cause of discontinuation) or progression to AP or BC.

    Measured: up to 24 months

  9. Event free survival (EFS)

    EFS is defined as the time from the first use of the study drug to the earliest occurrence of the following events during the study treatment: loss of CHR, loss of PCyCR, loss of CCyR, death from any cause during the treatment, and progression to AP or BC

    Measured: up to 24 months

  10. ABL mutation rate after 6 months of treatment

    The proportion of ABL mutations in subjects with BCR-ABL1IS > 1% or disease progression after 6 months of treatment

    Measured: up to 6 months

  11. Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib

    Evaluation of AEs, SAEs, and clinically relevant changes in laboratory tests according to laboratory reference ranges

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2021
  2. Study start10 May 2016
  3. Primary completion22 Oct 2018
  4. Study completion6 Dec 2019

Resources

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
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04925141
Sponsor's protocol ID
YNS-2015-V1.0
Status last verified
Jun 2021
First submitted
11 Jun 2021
Last updated
14 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dasatinib Tablets in people with Chronic Myelogenous Leukemia - Chronic Phase, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 4 sites 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 17 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 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

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 subjects who achieve and maintain major molecular response (MMR) at 12 months (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04925141.

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 14 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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