Asciminib Roll-over Study

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04877522

Collaborator

(none)

347

Enrollment

Location

Arms

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Myelogenous Leukemia Acute Lymphoblastic Leukemia	Drug: Asciminib single agent Drug: Asciminib Drug: Imatinib Drug: Nilotinib Drug: Bosutinib Drug: Dasatinib	Phase 4

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

347 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 16, 2022

Anticipated Primary Completion Date :

Aug 16, 2027

Anticipated Study Completion Date :

Aug 16, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Number of participabts with adverse events (AEs) and serious adverse events (SAEs) [5 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

Percentage of participants with clinical benefit as assessed by Investigator [5 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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: