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

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

Treatments tested in this trial

  • Asciminib single agent
  • Imatinib
  • Nilotinib
  • Bosutinib
  • Dasatinib
  • Asciminib single agent pediatric formulation

Treatment groups

347 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Sponsors and collaborators

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov