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Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response.

NCT03578367 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-04-21

Study results available
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Summary

To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP). An asciminib single agent arm (80 mg daily) was added after the primary analysis to evaluate if asciminib alone could lead to MR4.5 patients in Imatinib for at least one year who have never achieved deep molecular response (DMR).

Conditions

Interventions

DRUG

Asciminib add-on

Asciminib was supplied as 40 mg and 20 mg tablets and taken orally once daily.

DRUG

Imatinib

Imatinib was supplied as 400 mg and 100 mg tablets and taken orally once daily.

DRUG

Nilotinib

Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules and taken orally twice daily.

DRUG

Asciminib 80mg QD (asciminib single agent (ASAC))

Asciminib was supplied as 40 mg and 20 mg tablets and taken orally once daily (in the fasted state) on a continuous schedule (QD).

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-11-22
Primary Completion
2021-11-08
Completion
2025-02-26
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Poland
  • Portugal
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT03578367 on ClinicalTrials.gov