Asciminib Roll-over Study

Study Overview
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Brief Summary
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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
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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 the parent study, or from switching to asciminib (if they were on bosutinib in the parent study), but are unable to access this treatment outside of the clinical study.

Official Title
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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

Conditions
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Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Intervention / Treatment
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* Drug: Asciminib single agent
* Drug: Asciminib
* Drug: Imatinib
* Drug: Nilotinib
* Drug: Bosutinib
* Drug: Dasatinib


Participation Criteria
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Eligibility Criteria
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Key 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. Key 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 only for participants on bosutinib treatment that switch to asciminib treatment at enrollment: Asymptomatic pancreatitis abnormal ECG 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asciminib single agent group<br>Participants with CML or ALL, from Novartis sponsored asciminib studies, including but not limited to ABL001A2301, ABL001A2302, ABL001X2101, ABL001A2202, ABL001AUS04 and ABL001AUS08 studies, that were receiving asciminib | Drug: Asciminib single agent<br>* Taken orally, twice daily (BID) or once daily (QD), in fasting state<br>* Other names: ABL001;|
| Other: Bosutinib single agent group<br>Participants with CML-CP, from Novartis sponsored asciminib study ABL001A2301, that were receiving bosutinib | Drug: Bosutinib<br>* Taken orally, once daily, with food<br>|
| Experimental: Bosutinib-asciminib switch group<br>Participants with CML-CP, from Novartis sponsored asciminib study ABL001A2301 that were receiving bosutinib treatment and switched to asciminib when entering this study or during the course of this study | Drug: Asciminib single agent<br>* Taken orally, twice daily (BID) or once daily (QD), in fasting state<br>* Other names: ABL001;|
| Experimental: Asciminib in combination with imatinib group<br>Participants with CML from Novartis sponsored asciminib studies ABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib | Drug: Asciminib<br>* Taken orally, once daily, in the morning with low-fat meal or twice daily in fasting state<br>* Other names: ABL001;Drug: Imatinib<br>* Taken orally, once daily, in the morning with low-fat meal<br>* Other names: STI571;|
| Experimental: Asciminib in combination with nilotinib group<br>Participants with CML or ALL from Novartis sponsored asciminib studies ABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib | Drug: Asciminib<br>* Taken orally, once daily, in the morning with low-fat meal or twice daily in fasting state<br>* Other names: ABL001;Drug: Imatinib<br>* Taken orally, once daily, in the morning with low-fat meal<br>* Other names: STI571;|
| Other: Imatinib single agent group<br>Participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 that were receiving imatinib | Drug: Imatinib<br>* Taken orally, once daily, in the morning with low-fat meal<br>* Other names: STI571;|
| Other: Nilotinib single agent group<br>Participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 that were receiving nilotinib | Drug: Nilotinib<br>* Taken orally, twice daily, on an empty stomach<br>* Other names: AMN107;|
| Experimental: Asciminib in combination with dasatinib group<br>Participants with CML from Novartis sponsored study ABL001X2101 that were receiving asciminib with dasatinib | Drug: Dasatinib<br>* Taken orally, once daily in a fasted state, 1 or 2 hours before a meal<br>* Other names: Sprycel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participabts with adverse events (AEs) and serious adverse events (SAEs) | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with clinical benefit as assessed by Investigator | 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. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CML, Chronic Myelogenous Leukemia, ALL, CML-AP, CML-BP, CML-CP, myeloproliferative neoplasm, chronic phase, accelerated phase, blast phase, ABL001, asciminib