NCT04877522

Asciminib Roll-over Study

An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 347 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 7 Years – 100 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is an open-label, multi-center, global roll-over study designed to assess long term safety and provide continued treatment to participants who have previously participated in an asciminib Novartis sponsored study and who, in the opinion of the investigator, would benefit from continued treatment as in their parent study but are unable to access this treatment outside of the clinical study.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-30
• Primary completion: 2030-08-29
• Completion: 2030-08-30
• First posted: 2021-05-07
• Last updated: 2026-03-06

Locations

84 sites across 29 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

Regulatory

• FDA-regulated drug study