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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 347
- 试验地点
- 90
- 主要终点
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
详细描述
This is an open-label, multi-center, global roll-over study designed to assess long term safety and provide continued treatment to participants who have previously participated in an asciminib Novartis sponsored study and who, in the opinion of the investigator, would benefit from continued treatment as in their parent study but are unable to access this treatment outside of the clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant with PH+ CML or PH+ ALL currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib), imatinib, nilotinib or bosutinib alone within a Novartis-sponsored study and, in the opinion of the Investigator, would benefit from continued treatment.
- •Participant has demonstrated compliance on the parent study protocol and is willing and able to comply with scheduled visits, treatment plans and any other study procedures.
排除标准
- •Participant has been discontinued from parent study treatment.
- •Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.
- •Participant's ongoing treatment is currently approved and reimbursed at country level.
- •Pregnant or nursing (lactating) women.
- •Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.
- •Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.
- •Applicable for participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study that switch to asciminib treatment:
- •Asymptomatic (grade 2) pancreatitis if not resolved within 28 days
- •QTcF>480msec or inability to determine QTc interval
- •any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days before starting asciminib treatment
- •Other protocol-defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Nilotinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 and CABL001J12302 that were receiving nilotinib
干预措施: Nilotinib (Drug)
Bosutinib-Asciminib switch group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301 that were receiving bosutinib treatment and switched to asciminib when entering this study or during the course of this study
干预措施: Asciminib single agent (Drug)
Asciminib single agent group
Participants with CML or ALL, from Novartis sponsored asciminib studies, including but not limited to CABL001A2301, CABL001A2302, CABL001X2101, CABL001A2202, CABL001AUS04 and CABL001AUS08 studies, that were receiving asciminib
干预措施: Asciminib single agent (Drug)
Asciminib in combination with imatinib group
Participants with CML from Novartis sponsored asciminib studies CABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib
干预措施: Imatinib (Drug)
Bosutinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301, that were receiving bosutinib
干预措施: Bosutinib (Drug)
Asciminib single agent formulation for Pediatric
Participants with CML, from Novartis sponsored asciminib studies, including but not limited to CABL001I12201 study, that were receiving asciminib
干预措施: Asciminib single agent pediatric formulation (Drug)
Asciminib in combination with dasatinib group
Participants with CML from Novartis sponsored study CABL001X2101 that were receiving asciminib with dasatinib
干预措施: Dasatinib (Drug)
Dasatinib single agent group
Participant with CML-CP , from Novartis sponsored asciminib study CABL001A2202, CABL001J12301, that were receiving Dasatinib.
干预措施: Dasatinib (Drug)
Asciminib in combination with nilotinib group
Participants with CML or ALL from Novartis sponsored asciminib studies CABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib
干预措施: Nilotinib (Drug)
Imatinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 that were receiving imatinib
干预措施: Imatinib (Drug)
Dasatinib-Asciminib switch group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2202 that were receiving best available therapy (dasatinib) and switched to asciminib when entering this study or during the course of this study
干预措施: Asciminib single agent (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
时间窗: 8 years
All AEs and SAEs will be tabulated and listed for participants in the Safety Set by treatment group. From day of first administration of study treatment to 30 days after the last study treatment.
次要结局
- Percentage of participants with clinical benefit as assessed by Investigator(8 years)