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).
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
Drug | Synonyms | Arms |
---|
Dasatinib | | Dasatinib 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
Name | Type | Description | Interventions |
---|
Dasatinib 70 mg | Experimental | | |
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: | Recruiting |
Lead Sponsor: | Shenzhen Second People's Hospital |
Trial Keywords
Last Updated
June 10, 2021