OncRef

Clinical Trial: NCT04971226

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Novartis Pharmaceuticals
Information Provided By:Novartis
Last Update Posted:2026-08-28

Study Overview

Brief 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.

Official Title

A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

Conditions

Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive

Intervention / Treatment

  • Drug: Imatinib
  • Drug: Nilotinib
  • Drug: Bosutinib
  • Drug: Dasatinib
  • Drug: Asciminib

Other Study ID Numbers

  • CABL001J12301
  • 2023-508838-33-00
  • 2023

Start Date (Actual)

2021-10-06

Primary Completion Date (Actual)

2023-11-28

Study Completion Date (Estimated)

2031-01-18

Enrollment (Actual)

405

Study Type

Interventional

Phase

Phase 3