Asciminib Roll-over Study for Chronic Myelogenous Leukemia

This study is for people with Philadelphia chromosome-positive chronic myelogenous leukemia (PH+ CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (PH+ ALL) who are already taking asciminib, imatinib, nilotinib, or bosutinib in a Novartis-sponsored study. It's designed to let you continue receiving your current treatment if your doctor believes it's still beneficial. The main goal is to understand the long-term safety of these medications by tracking any side effects (adverse events) over 8 years. This study aims to enroll about 347 participants aged 7 to 100 years old.

Study design
This is an open-label, multi-center study, meaning both you and your doctors will know which medication you are receiving. It is designed to provide continued treatment to participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for adverse events and serious adverse events for 8 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04877522

Asciminib Roll-over Study

Recruiting
PHASE4Ages 7+InterventionalTreatment
Novartis Pharmaceuticals
~347 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Asciminib single agentImatinibNilotinibBosutinibDasatinibAsciminib single agent pediatric formulation

At a glance

Recruiting sites
59 of 85 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Measured over 8 years
Chronic Myelogenous Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
85 sites across 53 states
Spain7
France6
China5
Poland4
Russia4
South Korea3
Texas2
Austria2
  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Asymptomatic (grade 2) pancreatitis if not resolved within 28 days
QTcF\>480msec or inability to determine QTc interval
any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days before starting asciminib treatment
  • Number of participants with adverse events (AEs) and serious adverse events (SAEs)8 years

    All AEs and SAEs will be tabulated and listed for participants in the Safety Set by treatment group. From day of first administration of study treatment to 30 days after the last study treatment.