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Efficacy of asciminib in chronic phase CML patients with T315l mutations

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523491-23-00
Enrollment
50
Registered
2026-06-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-23

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

Conditions

Chronic Myeloid Leukemia

Brief summary

rate of MR2 at 12 months measured by BCR::ABL1 via PCR

Detailed description

Reduction of the size of the T315I positive BCR::ABL1 clone by NGS measurement, Rate of molecular response assessed by BCR-ABLIS monitoring at and by 6, 18, 24 months, Progression-free survival, probabilities of CML-related death, overall survival at and by end of study, Quality of life at enrolment and months 3, 6, 9, 12, 18, and 24 after start with asciminib

Interventions

DRUGAsciminib

Sponsors

Friedrich-Schiller-Universitaet Jena
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
rate of MR2 at 12 months measured by BCR::ABL1 via PCR

Secondary

MeasureTime frame
Reduction of the size of the T315I positive BCR::ABL1 clone by NGS measurement, Rate of molecular response assessed by BCR-ABLIS monitoring at and by 6, 18, 24 months, Progression-free survival, probabilities of CML-related death, overall survival at and by end of study, Quality of life at enrolment and months 3, 6, 9, 12, 18, and 24 after start with asciminib

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 24, 2026