Asciminib Roll-over Study

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04877522

Patient View

This open-label, global roll-over study evaluates long-term safety and provides continued treatment for participants with PH+ CML or PH+ ALL who benefited from prior Novartis-sponsored asciminib studies. Eligible participants must comply with study protocols and not have unresolved toxicities. Interventions include oral administration of asciminib, imatinib, nilotinib, bosutinib, or dasatinib.

Patient Parameters

Program Overview

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

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.

Eligibility Criteria

Inclusion Criteria

  1. 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.
  2. 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.

Key

Exclusion Criteria

  1. Participant has been discontinued from parent study treatment.

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

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

  4. Pregnant or nursing (lactating) women.

  5. Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.

  6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.

  7. Applicable for participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study that switch to asciminib treatment:

    • 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

Other protocol-defined Inclusion/Exclusion criteria may apply.

Get This Program In Your Inbox

You can sign up and apply your patients for this program.