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Asciminib Used in Consolidation With Imatinib vs. Imatinib to Achieve TFR in CP-CML

NCT05413915 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2025-05-21

No results posted yet for this study

Summary

The aim of this study is to establish if consolidation of imatinib-treated patients in stable DMR through the addition of asciminib, can lead to superior rates of TFR1, compared to imatinib alone in Chronic Phase-Chronic Myelogenous Leukemia patients.

Conditions

  • Chronic Myeloid Leukemia
  • Chronic Myeloid Leukemia, BCR/ABL-Positive
  • Chronic Myeloid Leukemia in Remission

Interventions

DRUG

Asciminib

Tyrosine kinase inhibitor

DRUG

Imatinib

Tyrosine kinase inhibitor

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Sarit Assouline

    lead OTHER

Principal Investigators

  • Sarit E Assouline, MD, MSc · SMBD Jewish General Hospital CIUSSS West Central Montreal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

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 NCT05413915 on ClinicalTrials.gov