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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT05734053
Collaborator
(none)
223
Enrollment
77
Locations
74.3
Actual Duration (Months)
2.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is 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.

Condition or Disease Intervention/Treatment Phase
  • Other: 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.

Study Design

Study Type:
Observational
Actual Enrollment :
223 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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.
Actual Study Start Date :
Jun 28, 2016
Actual Primary Completion Date :
Sep 8, 2022
Actual Study Completion Date :
Sep 8, 2022

Arms and Interventions

Arm Intervention/Treatment
Nilotinib

patients prescribed with nilotinib in routine medical practice

Other: Nilotinib
There is no treatment allocation. Patients administered Nilotinib by prescription can be enrolled.
Other Names:
  • Tasigna

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients in Major molecular response (MMR), and Deep molecular response according to international standard (MR^4.0 and MR^4.5) [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 [24 months]

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

    3. Duration of an MR4.0 and MR4.5 [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 [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. [24 months]

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

    6. Patient-reported QoL [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 [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 [24 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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,

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Freudenstadt Baden Wuerttemberg Germany 72250
    2 Novartis Investigative Site Augsburg Bavaria Germany 86152
    3 Novartis Investigative Site Bayreuth Bavaria Germany 95445
    4 Novartis Investigative Site Coburg Bavaria Germany 96450
    5 Novartis Investigative Site Kronach Bavaria Germany 96317
    6 Novartis Investigative Site Munich Bavaria Germany 80797
    7 Novartis Investigative Site Aschaffenburg Bayern Germany 63739
    8 Novartis Investigative Site Donauwoerth Bayern Germany 86609
    9 Novartis Investigative Site Landshut Bayern Germany 84028
    10 Novartis Investigative Site Frankfurt an der Oder Brandenburg Germany 15236
    11 Novartis Investigative Site Baden-Württemberg Heidenheim a.d.B Germany 89522
    12 Novartis Investigative Site Erbach Hessen Germany 64711
    13 Novartis Investigative Site Goettingen Lower Saxony Germany 37073
    14 Novartis Investigative Site Goslar Lower Saxony Germany 38642
    15 Novartis Investigative Site Twistringen Lower Saxony Germany 27239
    16 Novartis Investigative Site Hannover Niedersachsen Germany 30171
    17 Novartis Investigative Site Westerstede Niedersachsen Germany 26655
    18 Novartis Investigative Site Neuss Nordrhein-Westfalen Germany 41464
    19 Novartis Investigative Site Aachen North Rhine-Westphalia Germany 52064
    20 Novartis Investigative Site Ahaus Northrhine Westfalia Germany 48683
    21 Novartis Investigative Site Bad Salzuflen Northrhine Westfalia Germany 32105
    22 Novartis Investigative Site Hagen Northrhine Westfalia Germany 58095
    23 Novartis Investigative Site Iserlohn Northrhine Westfalia Germany 58644
    24 Novartis Investigative Site Neuwied Rhineland Palatinate Germany 56564
    25 Novartis Investigative Site Dresden Sachsen Germany 01127
    26 Novartis Investigative Site Zittau Sachsen Germany 02763
    27 Novartis Investigative Site Bad Schlema Saxony Germany 08301
    28 Novartis Investigative Site Reinbek Schleswig Holstein Germany 21465
    29 Novartis Investigative Site Altoetting Germany 84503
    30 Novartis Investigative Site Bad Liebenwerda Germany 04924
    31 Novartis Investigative Site Bad Mergentheim Germany 97980
    32 Novartis Investigative Site Bamberg Germany 96049
    33 Novartis Investigative Site Berlin Germany 10709
    34 Novartis Investigative Site Berlin Germany 12487
    35 Novartis Investigative Site Berlin Germany 13055
    36 Novartis Investigative Site Biberach Germany 88400
    37 Novartis Investigative Site Bielefeld Germany 33604
    38 Novartis Investigative Site Erfurt Germany 99084
    39 Novartis Investigative Site Erfurt Germany 99085
    40 Novartis Investigative Site Frankfurt Germany 60398
    41 Novartis Investigative Site Frankfurt Germany 60596
    42 Novartis Investigative Site Gera Germany 07548
    43 Novartis Investigative Site Halberstadt Germany 38820
    44 Novartis Investigative Site Halle Germany 06110
    45 Novartis Investigative Site Hamburg Germany 20259
    46 Novartis Investigative Site Hameln Germany 31785
    47 Novartis Investigative Site Hamm Germany 59063
    48 Novartis Investigative Site Hannover Germany 30161
    49 Novartis Investigative Site Heilbronn Germany 74072
    50 Novartis Investigative Site Heilbronn Germany 74078
    51 Novartis Investigative Site Hildesheim Germany 31135
    52 Novartis Investigative Site Köln Germany 50677
    53 Novartis Investigative Site Lemgo Germany 32657
    54 Novartis Investigative Site Ludwigsburg Germany 71636
    55 Novartis Investigative Site Memmingen Germany 87700
    56 Novartis Investigative Site Merseburg Germany 06217
    57 Novartis Investigative Site Moers Germany 47441
    58 Novartis Investigative Site Muenchen Germany 80331
    59 Novartis Investigative Site Neumuenster Germany 24534
    60 Novartis Investigative Site Nordhorn Germany 48527
    61 Novartis Investigative Site Nuernberg Germany 90403
    62 Novartis Investigative Site Nuernberg Germany 90449
    63 Novartis Investigative Site Offenburg Germany 77652
    64 Novartis Investigative Site Osnabrueck Germany 49076
    65 Novartis Investigative Site Porta Westfalica Germany 32457
    66 Novartis Investigative Site Potsdam Germany 14467
    67 Novartis Investigative Site Rotenburg Germany 27356
    68 Novartis Investigative Site Ruesselsheim Germany 65428
    69 Novartis Investigative Site Schorndorf Germany 73614
    70 Novartis Investigative Site Singen Germany 78224
    71 Novartis Investigative Site Speyer Germany 67346
    72 Novartis Investigative Site Stolberg Germany 52222
    73 Novartis Investigative Site Viersen Germany 45468
    74 Novartis Investigative Site Wiesbaden Germany 65191
    75 Novartis Investigative Site Wilhelmshaven Germany 26389
    76 Novartis Investigative Site Wolfsburg Germany 38440
    77 Novartis Investigative Site Wuerzburg Germany 97080

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05734053
    Other Study ID Numbers:
    • CAMN107ADE23
    First Posted:
    Feb 17, 2023
    Last Update Posted:
    Feb 17, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Novartis Pharmaceuticals
    Chronic myeloid leukemia
    CML
    NOFRETETE
    Nilotinib
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myelogenous, Chronic, BCR-ABL Positive

    Study Results

    No Results Posted as of Feb 17, 2023