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
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 347
- Locations
- 90
- Primary Endpoint
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Study Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 100 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Nilotinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 and CABL001J12302 that were receiving nilotinib
Intervention: 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
Intervention: 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
Intervention: 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
Intervention: Imatinib (Drug)
Bosutinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301, that were receiving bosutinib
Intervention: 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
Intervention: 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
Intervention: Dasatinib (Drug)
Dasatinib single agent group
Participant with CML-CP , from Novartis sponsored asciminib study CABL001A2202, CABL001J12301, that were receiving Dasatinib.
Intervention: 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
Intervention: Nilotinib (Drug)
Imatinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 that were receiving imatinib
Intervention: 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
Intervention: Asciminib single agent (Drug)
Outcomes
Primary Outcomes
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: 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.
Secondary Outcomes
- Percentage of participants with clinical benefit as assessed by Investigator(8 years)