CTRI/2024/10/075881进行中（未招募）4 期
A Prospective, Multicenter, Single-arm, Open-label, Phase IV, Post-authorization Interventional Study to Assess the Safety and Efficacy of Asciminib in Indian Patients with Ph positive CML-CP (Without T315I Mutation) Previously Treated with two or more Tyrosine Kinase Inhibitors and Ph Positive CML-CP with T315I Mutation.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 85
- 试验地点
- 12
- 主要终点
- 1. Frequency and severity of adverse events (AEs)/serious AEs (SAEs) in participants with Ph+ CML-CP (without T315I mutation), previously treated with 2 or more TKIs up to 6 months
研究概览
简要总结
This is Phase IV, prospective, multicenter, single arm, open-label, post-authorization interventional study to assess the safety and efficacy of Asciminib in Indian participants with Ph+ CML-CP (without T3151 mutation) previously treated with 2 or more TKIs and participants with Ph+ CML-CP with T3151 mutation irrespective of the line of treatment
The study will include 3 periods, a screening period (upto 21 Days), a treatment period of upto 6 months with Asciminib (with dosing according to mutation status) and a safety follow-up period for 30 days after the last dose of the study treatment. Completion of the safety follow-up period after the last dose of the study treatment will be considered as end of study (EOS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of Ph+ CML-CP.
- •Laboratory values as confirmed by the available reports of the peripheral blood test or bone marrow examination (performed within 12 months before the screening) at the screening visit to meet the criteria of Ph+ CML-CP: a) More than 15% blasts in peripheral blood and/or bone marrow b) More than 30% blasts plus promyelocytes in peripheral blood and/or bone marrow c) More than 20% basophils in the peripheral blood d) More than and equal to 50 x 109/L (≥50,000/mm3) platelets e) No evidence of extramedullary leukemic involvement, apart from hepatosplenomegaly
- •For Ph+ CML-CP participants with T315I mutation, mutational analysis testing at any time point showing a documented T315I mutation.
- •For Ph+ CML-CP participants without T315I mutation, at least 2 prior adenosine triphosphate (ATP)-site TKIs (i.e., imatinib, nilotinib, bosutinib, dasatinib, or ponatinib) with failure (adapted from the 2020 European Leukemia Net [ELN] Recommendations) or intolerance to the most recent TKI therapy at the time of screening.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •Evidence of typical BCR/ABL1 transcript (e14a2 and or e13a2) at the time of screening which is amenable to standardized RQ-PCR quantification.
- •Participants must have adequate end organ function as per the investigator’s judgement.
- •Participants must have the following electrolyte values within normal limits or corrected to be within normal limits with supplements prior to the first dose of study treatment: a.
- •Potassium (potassium increase of up to 6.0 mmol/L is acceptable at study entry if associated with creatinine clearance within normal limits).
- •Magnesium, except for magnesium increase more than upper level of normal (ULN) – 3.0 mg/dL or more than ULN – 1.23 mmol/L associated with creatinine clearance (calculated using Cockcroft-Gault formula) within normal limits.
排除标准
- •Known second chronic phase of CML after previous progression to CML-acute phase (AP)/CML-blast crisis (BC).
- •Previous treatment with a hematopoietic stem-cell transplantation.
- •Cardiac or cardiac repolarization abnormality, including any of the following: a.
- •History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, and coronary artery bypass graft (CABG) b.
- •Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block) c.
- •QT corrected for heart rate by Fridericia’s cube root formula (QTcF) at screening ≥450 msec (both male and female participants) d.
- •Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: i) Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
- •ii) Inability to determine the QTcF interval.
- •Concomitant medication(s) with a “Known risk of TdP†(per www.crediblemeds.org/) that cannot be discontinued or replaced 7 days prior to starting study treatment by safe alternative medication.
- •History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.
- •Known infection with human immunodeficiency virus (HIV) or active hepatitis B or C.
- •Known presence of significant congenital or acquired bleeding disorder unrelated to cancer.
- •Previous treatment with or known/suspected hypersensitivity to asciminib or any of its excipients.
- •Participants must avoid consumption of grapefruit, Seville oranges, or products containing the juice of each during the entire study and 7 days before the first dose of study treatment, due to potential CYP3A4 interaction with the study treatment.
- •Orange juice is allowed.
- •Participants must avoid consumption of over-the-counter medications or herbal supplements as these can interact with each other and may alter the effects of asciminib.
- •Participation in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer.
- •Pregnant or breastfeeding women.
- •Women of childbearing potential, defined as all women physiologically capable of becoming pregnant unless they are using highly effective methods of contraception.
- •If a participant is presenting with symptoms suggestive of possible Coronavirus Disease (COVID-19) infection, advise ruling it out by appropriate testing recommended by health authorities.
- •Nucleic acid amplification tests for viral RNA (polymerase chain reaction), to measure current infection with SARS-CoV-2
- •Antigen tests for rapid detection of SARS-CoV-2
- •Antibody (serology) tests to detect the presence of antibodies to SARS-CoV-2.
结局指标
主要结局
1. Frequency and severity of adverse events (AEs)/serious AEs (SAEs) in participants with Ph+ CML-CP (without T315I mutation), previously treated with 2 or more TKIs up to 6 months
时间窗: upto 6 months
2. Frequency and severity of AEs/SAEs in participants with Ph+ CML-CP with T315I mutation
时间窗: upto 6 months
次要结局
- Ph+ CML-CP Previously treated with 2 or more TKI’s (without T3151 mutation)(1. Proportion of participants with dose interruptions, reductions, & discontinuation up to 6 months)
- Ph+ CML-CP with T3151 mutation(1. Proportion of participants with dose interruptions, reductions, & discontinuation up to 6 months)
研究者
Dr Disha Shetty
Novartis Healthcare Private Limited
研究点 (12)
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