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A phase 2, multi-center, open-label, randomized study of oral asciminib added to imatinib versus continued imatinib versus switch to nilotinib in patients with CML-CP who have been previously treated with imatinib and have not achieved deep molecular response

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515040-23-00
Acronym
CABL001E2201
Enrollment
37
Registered
2024-09-20
Start date
2018-11-26
Completion date
2025-02-26
Last updated
2025-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with imatinib and have not achieved deep molecular response

Brief summary

Molecular Response (MR)4.5 rate at 48 weeks

Detailed description

• Molecular Response (MR)4.5 rate at 48 weeks • Difference in rate of MR4.5 at 48 weeks, • Rate of MR4.5 at 96 weeks • Rate of MR4.5 by 48 and 96 weeks • Sustained MR4.5 at 96 weeks • Time to MR4.5, Incidence and severity of adverse events, changes in laboratory values, clinically notable ECG abnormalities and vital signs, Plasma concentrations of asciminib and imatinib when administered in combination. PK parameters include but are not limited to Cmax, Tmax, Cmin, AUClast and AUCtau

Interventions

DRUGScemblix 40 mg film-coated tablets
DRUGScemblix 20 mg film-coated tablets
DRUGNILOTINIB
DRUGIMATINIB

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Molecular Response (MR)4.5 rate at 48 weeks—

Secondary

MeasureTime frame
• Molecular Response (MR)4.5 rate at 48 weeks • Difference in rate of MR4.5 at 48 weeks, • Rate of MR4.5 at 96 weeks • Rate of MR4.5 by 48 and 96 weeks • Sustained MR4.5 at 96 weeks • Time to MR4.5, Incidence and severity of adverse events, changes in laboratory values, clinically notable ECG abnormalities and vital signs, Plasma concentrations of asciminib and imatinib when administered in combination. PK parameters include but are not limited to Cmax, Tmax, Cmin, AUClast and AUCtau—

Countries

Austria, Czechia, France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026