Randomized, Open-Label, Phase II, Multicenter, Multi-Country Study to Evaluate Safety and Efficacy of Dasatinib 50 mg in First-Line Treatment of Early Chronic Phase Chronic Myeloid Leukemia

Hikma Pharmaceuticals LLC5 个研究点分布在 4 个国家目标入组 56 人2018年11月5日

适应症Chronic Myelogenous Leukemia

干预措施Dasatinib

概览

阶段: 2 期
干预措施: Dasatinib
疾病 / 适应症: Chronic Myelogenous Leukemia
发起方: Hikma Pharmaceuticals LLC
入组人数: 56
试验地点: 5
主要终点: Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test
状态: 已完成
最后更新: 2年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purpose of this multicenter randomized study is to compare efficacy and safety of dasatinib 50 mg once daily and dasatinib 100 mg once daily in patients with early chronic phase (CP) chronic myeloid leukemia (CML)

详细描述

A multicenter, prospective, open-label, randomized Phase II study to compare efficacy by measuring rates of major molecular response (MMR) at 12 months in patients with Ph+ chronic phase (CP) chronic myeloid leukemia (CML) randomized to receive either dasatinib 50 mg QD or dasatinib 100 mg QD. Approximately 100 patients are expected to be randomized. The duration of patient participation will be 18 months

注册库

clinicaltrials.gov

开始日期

2018年11月5日

结束日期

2023年7月22日

最后更新

2年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Hikma Pharmaceuticals LLC

责任方

Sponsor

入排标准

入选标准

•Age ≥ 18 years.
•Diagnosis of Ph+ or BCR-ABL positive CML in early CP (i.e. time from diagnosis \<12 months). Except for hydroxyurea and/or 1-2 doses of cytarabine (up to 6g/m2 total), patients must have received no or minimal prior therapy, defined as 30 days of prior approved tyrosine kinase inhibitor (TKI).
•Clonal evolution defined as the presence of additional chromosomal abnormalities other than the Ph-chromosome has been historically included as a criterion of accelerated phase (AP). However, patients with clonal evolution as the only criterion of AP have a significantly better prognosis, and when present at diagnosis may not impact the prognosis at all. Thus, patients with clonal evolution and no other criteria for AP will be eligible for this study.
•ECOG performance of 0-
•Adequate end organ function defined as the following: total bilirubin \<1.5x ULN (unless secondary to Gilbert's disease, in which case it should be \<2.5x 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

排除标准

•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 3 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 (\>460 msec)
•History of significant bleeding disorder unrelated to cancer including:
•Diagnosed congenital bleeding disorders (e.g. Von Willebrand's disease)
•Diagnosed acquired bleeding disorder within one year (e.g. acquired anti-factor VIII antibodies)
•Isolated thrombocytopenia without recurrent bleeding episodes shall be considered eligible for study entry

研究组 & 干预措施

Dasatinib 50 mg

Dasatinib 50 mg orally once daily

干预措施: Dasatinib

Dasatinib 100 mg

Dasatinib 100 mg orally once daily

干预措施: Dasatinib

结局指标

主要结局

Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test

时间窗: 12 months

Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1%

次要结局

Event free survival (EFS)(18 months)
Proportion of patients with MR 4.5 at 18 months(18 months)
Frequency of not taking the medications as prescribed(18 months)
Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib(18 months)
Overall survival(18 months)
Blastic phase (BP) transformation(18 months)
Transformation free survival (TFS) in eligible patients randomized to dasatinib 50 mg or dasatinib 100 mg treatment arms(18 months)
Proportion of patients with Complete cytogenetic response (CCyR) at 12 months(12 months)
Health-Related Quality of Life (HRQoL): EORTC QOLCML24(18 months)