Overview

Asciminib Roll-over Study

Status:
Not yet recruiting

Trial end date:
2026-07-10

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Imatinib Mesylate
Niacinamide

Criteria

Key Inclusion Criteria:

1. Participant with CML-CP that is currently receiving treatment with asciminib,
asciminib in combination with imatinib, imatinib alone, nilotinib alone or bosutinib
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. For participants in the USA and on asciminib treatment only: Sexually active males
unwilling to use a condom during intercourse while taking study treatment.

7. Applicable only for participants on bosutinib treatment that switch to asciminib
treatment at enrollment:

- Asymptomatic pancreatitis

- abnormal ECG

Other protocol-defined Inclusion/Exclusion criteria may apply.