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Tyrosine Kinase Inhibitor

Asciminib Continuation for Chronic Myelogenous Leukemia

Phase 4

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 years

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trialis for those who have completed a Novartis trial and may benefit from continued treatment.

Who is the study for?

This trial is for patients with certain types of leukemia (CML or ALL) who are already participating in a Novartis-sponsored study and taking asciminib alone or with other drugs like imatinib, nilotinib, dasatinib, or bosutinib. They should have followed the previous study's rules well and must be seen by their doctor as likely to benefit from continuing treatment.

What is being tested?

The trial is focused on long-term safety for those continuing treatment with asciminib, either as a single agent or combined with other leukemia medications such as imatinib, nilotinib, dasatinib, or bosutinib after completing an earlier Novartis-sponsored study.

What are the potential side effects?

While specific side effects aren't listed here, long-term use of leukemia treatments like asciminib and others can include risks such as liver problems, digestive issues, blood cell count changes leading to increased infection risk or bleeding problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Secondary study objectives

Percentage of participants with clinical benefit as assessed by Investigator

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

10Treatment groups

Experimental Treatment

Group I: Nilotinib single agent groupExperimental Treatment1 Intervention

Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 and CABL001J12302 that were receiving nilotinib

Group II: Imatinib single agent groupExperimental Treatment1 Intervention

Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 that were receiving imatinib

Group III: Dasatinib-Asciminib switch groupExperimental Treatment1 Intervention

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

Group IV: Dasatinib single agent groupExperimental Treatment1 Intervention

Participant with CML-CP , from Novartis sponsored asciminib study CABL001A2202, CABL001J12301, that were receiving Dasatinib.

Group V: Bosutinib-Asciminib switch groupExperimental Treatment1 Intervention

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

Group VI: Bosutinib single agent groupExperimental Treatment1 Intervention

Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301, that were receiving bosutinib

Group VII: Asciminib single agent groupExperimental Treatment1 Intervention

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

Group VIII: Asciminib in combination with nilotinib groupExperimental Treatment2 Interventions

Participants with CML or ALL from Novartis sponsored asciminib studies CABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib

Group IX: Asciminib in combination with imatinib groupExperimental Treatment1 Intervention

Participants with CML from Novartis sponsored asciminib studies CABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib

Group X: Asciminib in combination with dasatinib groupExperimental Treatment1 Intervention

Participants with CML from Novartis sponsored study CABL001X2101 that were receiving asciminib with dasatinib

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Imatinib

2011

Completed Phase 3

~3940