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ASCiminib, With or Without Dasatinib Combination, as a 2nd-Line Therapy to ADVANCE the Treatment for Chronic Myelogenous Leukemia in Chronic Phase (ASC2ADVANCE)

NCT07538401 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-04-20

No results posted yet for this study

Summary

This study is testing a new way to treat people with a type of blood cancer called chronic myeloid leukemia (CML) in chronic phase.

This study is for the patients whose first treatment with a drug called a tyrosine kinase inhibitor (TKI; standard therapy) did not work well and resistant to the TKI drug. The study is checking if a drug called Asciminib (having different way of action), used either by itself or with another drug called Dasatinib, can be a better second option to help control the CML.

Conditions

  • Chronic Myeloid Leukemia (CML) in

Interventions

DRUG

No high risk mutation

No HighRisk-Patients without a high-risk mutation profile will receive ASC monotherapy at a dose of 80 mg daily, in 28-day cycles, administered every 4 weeks.

DRUG

High Risk Mutation

Patients with a high-risk mutation profile will receive ASC 80 mg daily for the first 4 weeks (Cycle 1), followed by a combination of ASC 80 mg + DAS 100 mg daily starting from Cycle 2 onward.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • University Health Network, Toronto

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-25
Primary Completion
2028-04-25
Completion
2029-04-25

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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 NCT07538401 on ClinicalTrials.gov