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Completed

NCT Number: NCT05734053

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

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.

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Freudenstadt, Baden-Wurttemberg, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Nilotinib

Other

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

Other names: Tasigna

Primary outcomes

  1. Proportion of patients in Major molecular response (MMR), and Deep molecular response according to international standard (MR^4.0 and MR^4.5)

    Time frame: 24 months

    Proportion of patients in MMR, MR^4.0 and MR^4.5 was collected

  2. Time to achievement of an MR4.0 and MR4.5

    Time frame: 24 months

    Time to achievement of an MR4.0 and MR4.5 was collected

  3. Duration of an MR4.0 and MR4.5

    Time frame: 24 months

    Duration of an MR4.0 and MR4.5 was collected

  4. Proportion of patients whose molecular response is routinely analyzed by a MR4.5-certified laboratory

    Time frame: 24 months

    Proportion of patients whose molecular response is routinely analyzed by a MR4.5-certified laboratory was collected

  5. Proportion of European Treatment and Outcome Study for CML (EUTOS)-qualified laboratories that perform qRT-PCR.

    Time frame: 24 months

    Proportion of European Treatment and Outcome Study for CML (EUTOS)-qualified laboratories that perform qRT-PCR was documented

  6. Patient-reported QoL

    Time frame: 24 months

    The EORTC QLQ-C30 questionnaire in conjunction with the EORTC QLQ-CML24 module was used to assess patient-reported QoL.

  7. Patient adherence

    Time frame: 24 months

    Patient adherence was documented using the MMAS-8 (Morisky et al., 2008) patient questionnaire.

  8. Proportion of patients who discontinue Tyrosine kinase inhibitor (TKI) therapy

    Time frame: 24 months

    Proportion of patients who discontinue Tyrosine kinase inhibitor (TKI) therapy was documented

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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.

Acronym: NOFRETETE

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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