Health Trials

Asciminib Roll-over Study

ConditionsChronic Myelogenous LeukemiaLeukemia, Myelogenous, Chronic, BCR-ABL Positive
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age7-100
SponsorNovartis Pharmaceuticals

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant with PH+ CML or PH+ ALL currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib), imatinib, nilotinib or bosutinib alone within a Novartis-sponsored study and, in the opinion of the Investigator, would benefit from continued treatment.

Participant has demonstrated compliance on the parent study protocol and is willing and able to comply with scheduled visits, treatment plans and any other study procedures.

Disqualifiers

Participant has been discontinued from parent study treatment.

Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.

Participant's ongoing treatment is currently approved and reimbursed at country level.

Pregnant or nursing (lactating) women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Asciminib single agent

    Drug

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

  • Imatinib

    Drug

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

  • Nilotinib

    Drug

    Taken orally, twice daily, on an empty stomach

  • Bosutinib

    Drug

    Taken orally, once daily, with food

  • Dasatinib

    Drug

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

  • Asciminib single agent pediatric formulation

    Drug

    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.

Treatment groups

347 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Group A: Asciminib single agent groupExperimental treatment 1 intervention
Group B: Bosutinib single agent groupOther 1 intervention
Group C: Bosutinib-Asciminib switch groupExperimental treatment 1 intervention
Group D: Asciminib in combination with imatinib groupExperimental treatment 1 intervention
Group E: Asciminib in combination with nilotinib groupExperimental treatment 1 intervention
Group F: Imatinib single agent groupOther 1 intervention
Group G: Nilotinib single agent groupOther 1 intervention
Group H: Asciminib in combination with dasatinib groupExperimental treatment 1 intervention
Group I: Dasatinib single agent groupOther 1 intervention
Group J: Dasatinib-Asciminib switch groupExperimental treatment 1 intervention
Group K: Asciminib single agent formulation for PediatricExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

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.

Time frame
8 years

Secondary outcomes

1

Percentage of participants with clinical benefit as assessed by Investigator

Investigators' assessment of clinical benefit will collected through the Investigator confirming that the patient is still benefiting from treatment. This will be evaluated and tabulated for participants in the Safety Set by treatment group at each visit.

Time frame
8 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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