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

Chronic Myeloid Leukemia Clinical Trial

— NOFRETETE  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05734053
• Other study ID #: CAMN107ADE23
• Status: Completed
• Start date: June 28, 2016
• Est. completion date: September 8, 2022

Study information

• Verified date: August 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: September 8, 2022
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Other:
• Nilotinib
There was no treatment allocation. Patients administered Nilotinib by prescription could be enrolled.

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Aachen	North Rhine-Westphalia
Germany	Novartis Investigative Site	Ahaus	Northrhine Westfalia
Germany	Novartis Investigative Site	Altoetting
Germany	Novartis Investigative Site	Aschaffenburg	Bayern
Germany	Novartis Investigative Site	Augsburg	Bavaria
Germany	Novartis Investigative Site	Bad Liebenwerda
Germany	Novartis Investigative Site	Bad Mergentheim
Germany	Novartis Investigative Site	Bad Salzuflen	Northrhine Westfalia
Germany	Novartis Investigative Site	Bad Schlema	Saxony
Germany	Novartis Investigative Site	Baden-Württemberg	Heidenheim a.d.B
Germany	Novartis Investigative Site	Bamberg
Germany	Novartis Investigative Site	Bayreuth	Bavaria
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Biberach
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Coburg	Bavaria
Germany	Novartis Investigative Site	Donauwoerth	Bayern
Germany	Novartis Investigative Site	Dresden	Sachsen
Germany	Novartis Investigative Site	Erbach	Hessen
Germany	Novartis Investigative Site	Erfurt
Germany	Novartis Investigative Site	Erfurt
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt an der Oder	Brandenburg
Germany	Novartis Investigative Site	Freudenstadt	Baden Wuerttemberg
Germany	Novartis Investigative Site	Gera
Germany	Novartis Investigative Site	Goettingen	Lower Saxony
Germany	Novartis Investigative Site	Goslar	Lower Saxony
Germany	Novartis Investigative Site	Hagen	Northrhine Westfalia
Germany	Novartis Investigative Site	Halberstadt
Germany	Novartis Investigative Site	Halle
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hameln
Germany	Novartis Investigative Site	Hamm
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hannover	Niedersachsen
Germany	Novartis Investigative Site	Heilbronn
Germany	Novartis Investigative Site	Heilbronn
Germany	Novartis Investigative Site	Hildesheim
Germany	Novartis Investigative Site	Iserlohn	Northrhine Westfalia
Germany	Novartis Investigative Site	Köln
Germany	Novartis Investigative Site	Kronach	Bavaria
Germany	Novartis Investigative Site	Landshut	Bayern
Germany	Novartis Investigative Site	Lemgo
Germany	Novartis Investigative Site	Ludwigsburg
Germany	Novartis Investigative Site	Memmingen
Germany	Novartis Investigative Site	Merseburg
Germany	Novartis Investigative Site	Moers
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Munich	Bavaria
Germany	Novartis Investigative Site	Neumuenster
Germany	Novartis Investigative Site	Neuss	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Neuwied	Rhineland Palatinate
Germany	Novartis Investigative Site	Nordhorn
Germany	Novartis Investigative Site	Nuernberg
Germany	Novartis Investigative Site	Nuernberg
Germany	Novartis Investigative Site	Offenburg
Germany	Novartis Investigative Site	Osnabrueck
Germany	Novartis Investigative Site	Porta Westfalica
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Reinbek	Schleswig Holstein
Germany	Novartis Investigative Site	Rotenburg
Germany	Novartis Investigative Site	Ruesselsheim
Germany	Novartis Investigative Site	Schorndorf
Germany	Novartis Investigative Site	Singen
Germany	Novartis Investigative Site	Speyer
Germany	Novartis Investigative Site	Stolberg
Germany	Novartis Investigative Site	Twistringen	Lower Saxony
Germany	Novartis Investigative Site	Viersen
Germany	Novartis Investigative Site	Westerstede	Niedersachsen
Germany	Novartis Investigative Site	Wiesbaden
Germany	Novartis Investigative Site	Wilhelmshaven
Germany	Novartis Investigative Site	Wolfsburg
Germany	Novartis Investigative Site	Wuerzburg
Germany	Novartis Investigative Site	Zittau	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients in Major molecular response (MMR), and Deep molecular response according to international standard (MR^4.0 and MR^4.5)	Proportion of patients in MMR, MR^4.0 and MR^4.5 was collected	24 months
Primary	Time to achievement of an MR4.0 and MR4.5	Time to achievement of an MR4.0 and MR4.5 was collected	24 months
Primary	Duration of an MR4.0 and MR4.5	Duration of an MR4.0 and MR4.5 was collected	24 months
Primary	Proportion of patients whose molecular response is routinely analyzed by a MR4.5-certified laboratory	Proportion of patients whose molecular response is routinely analyzed by a MR4.5-certified laboratory was collected	24 months
Primary	Proportion of European Treatment and Outcome Study for CML (EUTOS)-qualified laboratories that perform qRT-PCR.	Proportion of European Treatment and Outcome Study for CML (EUTOS)-qualified laboratories that perform qRT-PCR was documented	24 months
Primary	Patient-reported QoL	The EORTC QLQ-C30 questionnaire in conjunction with the EORTC QLQ-CML24 module was used to assess patient-reported QoL.	24 months
Primary	Patient adherence	Patient adherence was documented using the MMAS-8 (Morisky et al., 2008) patient questionnaire.	24 months
Primary	Proportion of patients who discontinue Tyrosine kinase inhibitor (TKI) therapy	Proportion of patients who discontinue Tyrosine kinase inhibitor (TKI) therapy was documented	24 months

External Links

•   Results for Study CAMN107ADE23 that is getting linked from the Novartis Clinical Trials Website