Nilotinib for Patients With Chronic Myeloid Leukemia in First Line and Any Subsequent Line (NOFRETETE)

Novartis

Status: Completed

Conditions: Chronic Myeloid Leukemia

Treatments: Other: Nilotinib

Study type: Observational

Funder types: Industry

Identifiers

NCT05734053

CAMN107ADE23

Details and patient eligibility

About

This was a non-interventional observational study within the routine chronic myeloid leukemia treatment practice; no further tests were required apart from the assessments routinely performed for Chronic myeloid leukemia patients treated with nilotinib.

Full description

The observation period per patient was 24 months. All patients were treated with nilotinib in accordance to the clinical routine at the respective institution and the summary of product characteristics (SmPC).

The observation intervals (documentation at baseline and at about 3, 6, 9, 12, 18 and 24 months) were not fixed and were aligned with the regular treatment schedule and the clinical symptoms of each patient. The medical decision about the schedule as well as therapeutic and diagnostic measures was made solely by the responsible physician. Patients who discontinued treatment within two years of the observation period were followed until starting a new TKI therapy line, however with a maximum time period of six months. All other patients that reached the official end of treatment after completion of the 24-month observation period were followed up for 28 days.

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients diagnosed with Ph+ CML (or evidence of BCR-ABL transcript) treated with nilotinib under routine medical practice and the SmPC, as amended, in first or any subsequent line, if the current therapy with nilotinib has not been in place for more than twelve months. Retrospective documentation of patients for up to one year will be permitted.
• Patients who have already had an interruption/discontinuation of nilotinib therapy.
• Patients who have been informed about this NIS and have personally dated and signed their informed consent form.

Exclusion criteria

• There are no exclusion criteria, apart from the contraindications mentioned in the SmPC. Participating patients are not allowed to take part in a clinical trial in parallel,

Trial design

222 participants in 1 patient group

Nilotinib

Description:

patients prescribed with nilotinib in routine medical practice

Treatment:

Other: Nilotinib