RecruitingPhase 4

Asciminib Roll-over Study

United States347 participantsStarted 2022-08-30

Plain-language 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

Who can participate

Age range7 Years – 100 Years

SexALL

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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.

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 for participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study that switch to asciminib treatment:

What they're measuring

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

Timeframe: 8 years

Trial details

NCT IDNCT04877522

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-08-29

Contact for this trial

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

View on ClinicalTrials.gov More Chronic Myelogenous Leukemia trials