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A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

NCT04971226 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2026-04-06

Study results available
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Summary

The study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator selected Tyrosine Kinase Inhibitor (TKI) for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The Investigator selected TKI will be one of the following treatment options for first-line treatment of CML-CP - imatinib 400 mg QD or nilotinib 300 mg BID or dasatinib 100 mg QD or bosutinib 400 mg QD.

This study has three periods: 1. Treatment period for all randomized participants, 2. Optional Treatment-Free Remission (TFR) period only for participants meeting TFR eligibility criteria and 3. Treatment Re-Initiation (TRI) period only for participants who relapsed after TFR attempt.

Conditions

  • Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive

Interventions

DRUG

Imatinib

Comes in 100 mg and 400 mg tablets and taken orally

DRUG

Nilotinib

Comes in 150 mg and 200 mg capsules and taken orally

DRUG

Bosutinib

Comes in 100 mg and 400 mg tablets and taken orally

DRUG

Dasatinib

Comes in 20 mg, 50 mg, 70 mg and 100 mg tablets and taken orally

DRUG

Asciminib

Comes in 40 mg tablets and taken orally

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2023-11-28
Completion
2031-01-18
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • China
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Norway
  • Portugal
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT04971226 on ClinicalTrials.gov