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Asciminib Treatment Optimization in ≥ 3rd Line CML-CP

NCT04948333 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2026-03-18

Study results available
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Summary

The purpose of the study is to optimize the treatment of asciminib in patients with chronic myelogenous leukemia in chronic phase (CML-CP) previously treated with 2 or more Tyrosine Kinase Inhibitors (TKIs).

Conditions

  • Chronic Myelogenous Leukemia

Interventions

DRUG

ABL001 40mg BID

One tablet of 40 mg will be taken orally twice a day (BID)

DRUG

ABL001 80mg QD

Two tablets of 40 mg will be taken orally once a day (QD)

DRUG

ABL001 200mg QD

Five tablets of 40 mg will be taken orally once a day (QD)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-13
Primary Completion
2024-03-12
Completion
2026-02-25

Countries

  • Argentina
  • Austria
  • Brazil
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Malaysia
  • Oman
  • Poland
  • Singapore
  • South Korea
  • Spain
  • United Kingdom
  • Vietnam

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 NCT04948333 on ClinicalTrials.gov