BCR-ABL, Chronic Myeloid Leukemia, Dasatinib
Conditions
Keywords
Dasatinib, CML-CP
Brief 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).
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.
Interventions
DRUGDasatinib
70 mg of Dasatinib orally daily for 12 months
Sponsors
Shenzhen Second People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test | 12 months | Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with MR 4.0 at 12 months. | 12 months | Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01% |
| Proportion of patients with MR 4.5 at 12 months. | 12 months | Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032% |
| Proportion of patients with Complete cytogenetic response (CCyR) at 12 months | 12 months | defined as 0% Ph+ metaphases, or FISH ≤2%, or BCR-ABL transcripts (IS) ≤1% |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib | 18 months | Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges |
Countries
China
Contacts
Primary ContactXin Du
Outcome results
None listed