EUCTR2021-000602-17-DK进行中（未招募）1 期
An open label, multi-center asciminib roll-over study to assess long-term safety in patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 660
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent must be obtained prior to participation in the study.
- •2. Participant with Ph+ CML or Ph+ ALL, currently enrolled in a Novartis-sponsored study, that has completed treatment phase and has fulfilled the requirements for the primary objective, receiving:
- •-asciminib
- •-asciminib in combination with imatinib or nilotinib or dasatinib
- •-nilotinib
- •-bosutinib
- •and, in the opinion of the Investigator, would benefit from continued treatment.
- •3. Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements and is willing and able to comply with scheduled visits, treatment plans and any other study procedures.
- •4. Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 260
排除标准
- •1. Participant has been discontinued from parent study treatment due to any reason.
- •2. Participant currently has unresolved toxicities of grade 3 or 4 reported as possibly related to study treatment in the parent study, which have:
- •- not resolved to Grade 2 or lower within 42 days and /or require dose interruption for longer than 42 days for hematological toxicities,
- •- not resolved to Grade 2 or lower within 28 days and /or require dose interruption for longer than 28 days in case of non-hematological toxicities.
- •3. Participant’s ongoing treatment is currently approved and reimbursed at country level.
- •4. Pregnant or nursing (lactating) women.
- •5b. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 3 days after stopping asciminib. If local regulations or locally approved prescribing information are more stringent than the protocol required duration of contraception (Section 8.4.3), local regulations or locally approved prescribing information apply and will be described in the ICF. Participants receiving imatinib, nilotinib bosutinib or dasatinib should be willing to follow the respective contraception requirements as in the local prescribing information.
- •6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib should be willing to follow the relevant contraception requirements as in the local prescribing information.
- •7a. Applicable only for participants on bosutinib treatment at the end of the CABL001A2301 study that switch to asciminib treatment at enrollment:
- •-Any Grade 3 or 4 toxicity which has not resolved to Grade 2 or lower within 28 days before starting asciminib treatment.
- •-Asymptomatic (grade 2) pancreatitis if not resolved within 28 days.
- •-QTcF > 480 msec or inability to determine QTc interval
- •8. Other protocol-defined exclusion criteria may apply
研究者
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