NCT05734053

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

Nilotinib for Patients With Chronic Myeloid Leukemia in First Line and Any Subsequent Line - a Non-interventional Study on the Assessment of Deep Molecular Response in CML Patients in Daily Routine.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 222 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
OTHER	Nilotinib	There was no treatment allocation. Patients administered Nilotinib by prescription could be enrolled.

Timeline

• Start date: 2016-06-28
• Primary completion: 2022-09-08
• Completion: 2022-09-08
• First posted: 2023-02-17
• Last updated: 2023-08-21

Locations

77 sites across 1 country: Germany