Clinical trial NCT04155411: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dasatinib
BCR-ABL
Chronic Myeloid Leukemia
Keywords: Dasatinib, CML-CP
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of patients with MR 4.0 at 12 months.
timeFrame: 12 months
measure: Proportion of patients with MR 4.5 at 12 months.
timeFrame: 12 months
measure: Proportion of patients with Complete cytogenetic response (CCyR) at 12 months
timeFrame: 12 months
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib
timeFrame: 18 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Xin Du
state: Guangdong
Study officials:
References: