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Asciminib Roll-over Study

NCT04877522 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2026-05-11

No results posted yet for this study

Summary

This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment

Conditions

  • Chronic Myelogenous Leukemia
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

DRUG

Asciminib single agent

Taken orally, twice daily (BID) or once daily (QD), in fasting state

DRUG

Imatinib

Taken orally, once daily, in the morning with low-fat meal

DRUG

Nilotinib

Taken orally, twice daily, on an empty stomach

DRUG

Bosutinib

Taken orally, once daily, with food

DRUG

Dasatinib

Taken orally, once daily in a fasted state, 1 or 2 hours before a meal

DRUG

Asciminib single agent pediatric formulation

Pediatric participants receive a body weight adjusted dose of 1.3 mg/kg of pediatric film coated granules with food twice daily (b.i.d.) or 2.6 mg/kg once daily (q.d.) in the morning.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-08-30
Primary Completion
2030-08-30
Completion
2030-08-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Lebanon
  • Malaysia
  • Mexico
  • Oman
  • Poland
  • Portugal
  • Romania
  • Russia
  • Saudi Arabia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

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 NCT04877522 on ClinicalTrials.gov