Asciminib Long-Term Safety Study for Patients Continuing Treatment

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04877522

Provider View

This study is for patients who have completed a previous Novartis study with asciminib and are considered by their doctor to benefit from continuing the treatment. It aims to ensure the long-term safety of the medication.

Patient Parameters

Program Overview

This study is designed to provide ongoing treatment and monitor the long-term safety of asciminib for patients who have already participated in a Novartis-sponsored study. If the doctor believes that continuing the treatment is beneficial, and the patient cannot access it outside the study, they can join this roll-over study.

Description

This is an open-label study, meaning both the doctors and patients know what treatment is being given. It takes place in multiple centers around the world and is for patients who have been part of a previous Novartis study with asciminib. The goal is to continue providing the treatment and to monitor its long-term safety. Patients who are considered to benefit from ongoing treatment but cannot get it outside the study can participate.

Eligibility Criteria

Inclusion Criteria

  • Currently receiving treatment with asciminib, either alone or with other medications like imatinib, nilotinib, or dasatinib, as part of a Novartis study.
  • Diagnosed with PH+ Chronic Myeloid Leukemia (CML) or PH+ Acute Lymphoblastic Leukemia (ALL).
  • The doctor believes continued treatment is beneficial.
  • Has followed the rules and schedule of the previous study and is willing to do the same in this study.

Exclusion Criteria

  • Stopped treatment in the previous study.
  • Has unresolved side effects from the previous study treatment.
  • Can get the treatment approved and paid for outside the study.
  • Pregnant or breastfeeding women.
  • Women who can become pregnant must use effective birth control and agree to continue while on the study.
  • Men taking certain medications must agree to follow birth control guidelines.
  • For those switching to asciminib from other treatments:
    • Unresolved mild pancreatitis within 28 days.
    • Heart rhythm issues that cannot be measured or are too high.
    • Severe side effects not improved to a mild level within 28 days before starting asciminib.
  • Other specific criteria may apply.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.