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Efficacy of Asciminib in Chronic Phase CML Patients With T315I Mutations

NCT07789574 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-27

No results posted yet for this study

Summary

This is a multi-center, prospective, single-arm, non-randomized, interventional phase II study of CML patients in first or second chronic phase (i.e. after allogeneic stem cell transplantation) and proven BCR::ABL1 T315I mutation. All patients will be treated with asciminib 200 mg BID. 50 patients will be enrolled from approximately 20 study sites in Germany.

Conditions

  • Chronic Myeloid Leukemia (CML)

Interventions

DRUG

asciminib 200 mg BID

All patients will be treated with asciminib 200 mg BID.

Sponsors & Collaborators

  • Thomas Ernst, PD Dr. med.

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-22
Primary Completion
2030-06-30
Completion
2030-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07789574 on ClinicalTrials.gov