Asciminib Roll-over Study

Novartis

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Imatinib; Drug: Bosutinib; Drug: Asciminib single agent; Drug: Nilotinib; Drug: Dasatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04877522

2021-000602-17 (EudraCT Number)

CABL001A2001B

2023-507557-16-00 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 347 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. 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.
2. 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:

1. Participant has been discontinued from parent study treatment.

2. Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.

3. Participant's ongoing treatment is currently approved and reimbursed at country level.

4. Pregnant or nursing (lactating) women.

5. Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.

6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.

7. 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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347 participants in 10 patient groups

Asciminib single agent group

Experimental group

Description:

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

Treatment:

Drug: Asciminib single agent

Bosutinib single agent group

Other group

Description:

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

Treatment:

Drug: Bosutinib

Bosutinib-Asciminib switch group

Experimental group

Description:

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

Treatment:

Drug: Asciminib single agent

Asciminib in combination with imatinib group

Experimental group

Description:

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

Treatment:

Drug: Imatinib

Asciminib in combination with nilotinib group

Experimental group

Description:

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

Treatment:

Drug: Nilotinib

Imatinib single agent group

Other group

Description:

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

Treatment:

Drug: Imatinib

Nilotinib single agent group

Other group

Description:

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

Treatment:

Drug: Nilotinib

Asciminib in combination with dasatinib group

Experimental group

Description:

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

Treatment:

Drug: Dasatinib

Dasatinib single agent group

Other group

Description:

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

Treatment:

Drug: Dasatinib

Dasatinib-Asciminib switch group

Experimental group

Description:

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

Treatment:

Drug: Asciminib single agent