Clinical Trials /

Dose Reduced Dasatinib (70 mg Daily) as First-line Treatment for Newly Diagnosed CML-CP

NCT04155411

Description:

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).

Related Conditions:
  • Chronic Myeloid Leukemia
Recruiting Status:

Not yet recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Dose Reduced Dasatinib (70 mg Daily) as First-line Treatment for Newly Diagnosed CML-CP
  • Official Title: Efficacy and Safety of Dasatinib 70 mg as First-Line Treatment for Newly Diagnosed Chronic‐Phase Chronic Myeloid Leukemia (CML-CP)

Clinical Trial IDs

  • ORG STUDY ID: 20191103
  • NCT ID: NCT04155411

Conditions

  • Dasatinib
  • BCR-ABL
  • Chronic Myeloid Leukemia

Interventions

DrugSynonymsArms
DasatinibDasatinib 70 mg

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Dasatinib 70 mgExperimental
  • Dasatinib

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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.

          -  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.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test
Time Frame:12 months
Safety Issue:
Description:Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1%

Secondary Outcome Measures

Measure:Proportion of patients with MR 4.0 at 12 months.
Time Frame:12 months
Safety Issue:
Description:Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01%
Measure:Proportion of patients with MR 4.5 at 12 months.
Time Frame:12 months
Safety Issue:
Description:Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032%
Measure:Proportion of patients with Complete cytogenetic response (CCyR) at 12 months
Time Frame:12 months
Safety Issue:
Description:defined as 0% Ph+ metaphases, or FISH ≤2%, or BCR-ABL transcripts (IS) ≤1%
Measure:Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib
Time Frame:18 months
Safety Issue:
Description:Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Shenzhen Second People's Hospital

Trial Keywords

  • Dasatinib, CML-CP

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