Asciminib Roll-over Study
- Conditions
- Chronic Myelogenous LeukemiaLeukemia, Myelogenous, Chronic, BCR-ABL Positive
- Interventions
- Registration Number
- NCT04877522
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 347
- 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.
Key
-
Participant has been discontinued from parent study treatment.
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Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.
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Participant's ongoing treatment is currently approved and reimbursed at country level.
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Pregnant or nursing (lactating) women.
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Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.
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Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bosutinib single agent group Bosutinib Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301, that were receiving bosutinib Imatinib single agent group Imatinib Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 that were receiving imatinib Bosutinib-Asciminib switch group Asciminib single agent 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 Asciminib single agent group Asciminib single agent 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 Asciminib in combination with nilotinib group Nilotinib Participants with CML or ALL from Novartis sponsored asciminib studies CABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib Asciminib in combination with imatinib group Imatinib Participants with CML from Novartis sponsored asciminib studies CABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib Dasatinib-Asciminib switch group Asciminib single agent 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 Nilotinib single agent group Nilotinib Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 and CABL001J12302 that were receiving nilotinib Asciminib in combination with dasatinib group Dasatinib Participants with CML from Novartis sponsored study CABL001X2101 that were receiving asciminib with dasatinib Dasatinib single agent group Dasatinib Participant with CML-CP , from Novartis sponsored asciminib study CABL001A2202, CABL001J12301, that were receiving Dasatinib.
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) and serious adverse events (SAEs) 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 Outcome Measures
Name Time Method Percentage of participants with clinical benefit as assessed by Investigator 8 years Investigators' assessment of clinical benefit will collected through the Investigator confirming that the patient is still benefiting from treatment. This will be evaluated and tabulated for participants in the Safety Set by treatment group at each visit.
Trial Locations
- Locations (5)
Michigan Med University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Memorial Sloan Kettering
🇺🇸New York, New York, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Uni Of TX MD Anderson Cancer Cntr
🇺🇸Houston, Texas, United States
Novartis Investigative Site
🇬🇧Oxford, United Kingdom