Health Trials

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.

Locations

85
Argentina
Novartis Investigative SiteC1221ADC, CABABuenos Aires, Argentina
Novartis Investigative SiteC1114AAN, Capital Federal Argentina
Austria
Novartis Investigative Site8036, Graz Austria
Novartis Investigative Site1140, Vienna Austria

Sponsors and collaborators

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov