Chronic Myeloid LeukemiaNOFRETETENCT05734053
Nilotinib for Patients With Chronic Myeloid Leukemia in First Line and Any Subsequent Line
An observational study of Chronic Myeloid Leukemia, run by Novartis Pharmaceuticals at 77 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- Nilotinib
- How many people
- 222 participants
- Where
- 77 sitesGermany
- Study dates
- 28 Jun 2016to 8 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult male and female patients with diagnosed Philadelphia chromosome positive (Ph+) and/or Breakpoint cluster region-Abelson tyrosine kinase (Abelson murine leukemia proto-oncogene)+ Chronic myeloid leukemia who were being treated with nilotinib in first or any subsequent line and for whom treatment with nilotinib was indicated according to SmPC
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
77 sites in 1 country.
77 sites in 1 country
Germany77 sites
Novartis Investigative Site
Aachen, North Rhine-Westphalia, 52064
Novartis Investigative Site
Ahaus, Northrhine Westfalia, 48683
Novartis Investigative Site
Altötting, 84503
Novartis Investigative Site
Aschaffenburg, Bavaria, 63739
Novartis Investigative Site
Augsburg, Bavaria, 86152
Novartis Investigative Site
Bad Liebenwerda, 04924
Novartis Investigative Site
Bad Mergentheim, 97980
Novartis Investigative Site
Bad Salzuflen, Northrhine Westfalia, 32105
Novartis Investigative Site
Bad Schlema, Saxony, 08301
Novartis Investigative Site
Baden-Württemberg, Heidenheim a.d.B, 89522
Novartis Investigative Site
Bamberg, 96049
Novartis Investigative Site
Bayreuth, Bavaria, 95445
Novartis Investigative Site
Berlin, 10709
Novartis Investigative Site
Berlin, 12487
Novartis Investigative Site
Berlin, 13055
Novartis Investigative Site
Biberach, 88400
Novartis Investigative Site
Bielefeld, 33604
Novartis Investigative Site
Coburg, Bavaria, 96450
Novartis Investigative Site
Cologne, 50677
Novartis Investigative Site
Donauwörth, Bavaria, 86609
Novartis Investigative Site
Dresden, Saxony, 01127
Novartis Investigative Site
Erbach im Odenwald, Hesse, 64711
Novartis Investigative Site
Erfurt, 99084
Novartis Investigative Site
Erfurt, 99085
Novartis Investigative Site
Frankfurt, 60398
Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Frankfurt (Oder), Brandenburg, 15236
Novartis Investigative Site
Freudenstadt, Baden-Wurttemberg, 72250
Novartis Investigative Site
Gera, 07548
Novartis Investigative Site
Goslar, Lower Saxony, 38642
Novartis Investigative Site
Göttingen, Lower Saxony, 37073
Novartis Investigative Site
Hagen, Northrhine Westfalia, 58095
Novartis Investigative Site
Halberstadt, 38820
Novartis Investigative Site
Halle, 06110
Novartis Investigative Site
Hamburg, 20259
Novartis Investigative Site
Hamelin, 31785
Novartis Investigative Site
Hamm, 59063
Novartis Investigative Site
Hanover, Lower Saxony, 30171
Novartis Investigative Site
Hanover, 30161
Novartis Investigative Site
Heilbronn, 74072
Novartis Investigative Site
Heilbronn, 74078
Novartis Investigative Site
Hildesheim, 31135
Novartis Investigative Site
Iserlohn, Northrhine Westfalia, 58644
Novartis Investigative Site
Kronach, Bavaria, 96317
Novartis Investigative Site
Landshut, Bavaria, 84028
Novartis Investigative Site
Lemgo, 32657
Novartis Investigative Site
Ludwigsburg, 71636
Novartis Investigative Site
Memmingen, 87700
Novartis Investigative Site
Merseburg, 06217
Novartis Investigative Site
Moers, 47441
Novartis Investigative Site
München, 80331
Novartis Investigative Site
Munich, Bavaria, 80797
Novartis Investigative Site
Neumünster, 24534
Novartis Investigative Site
Neuss, North Rhine-Westphalia, 41464
Novartis Investigative Site
Neuwied, Rhineland-Palatinate, 56564
Novartis Investigative Site
Nordhorn, 48527
Novartis Investigative Site
Nuremberg, 90403
Novartis Investigative Site
Nuremberg, 90449
Novartis Investigative Site
Offenburg, 77652
Novartis Investigative Site
Osnabrück, 49076
Novartis Investigative Site
Porta Westfalica, 32457
Novartis Investigative Site
Potsdam, 14467
Novartis Investigative Site
Reinbek, Schleswig-Holstein, 21465
Novartis Investigative Site
Rotenburg (Wümme), 27356
Novartis Investigative Site
Rüsselsheim am Main, 65428
Novartis Investigative Site
Schorndorf, 73614
Novartis Investigative Site
Singen, 78224
Novartis Investigative Site
Speyer, 67346
Novartis Investigative Site
Stolberg, 52222
Novartis Investigative Site
Twistringen, Lower Saxony, 27239
Novartis Investigative Site
Viersen, 45468
Novartis Investigative Site
Westerstede, Lower Saxony, 26655
Novartis Investigative Site
Wiesbaden, 65191
Novartis Investigative Site
Wilhelmshaven, 26389
Novartis Investigative Site
Wolfsburg, 38440
Novartis Investigative Site
Würzburg, 97080
Novartis Investigative Site
Zittau, Saxony, 02763
About this study
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.
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.
Read the 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
- Being tested
- Nilotinib
- Keywords
- Chronic myeloid leukemia, CML, NOFRETETE, Nilotinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NilotinibOther
Also called Tasigna
There was no treatment allocation. Patients administered Nilotinib by prescription could be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Nilotinib | patients prescribed with nilotinib in routine medical practice Receives: Other: Nilotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Time to achievement of an MR4.0 and MR4.5
Time to achievement of an MR4.0 and MR4.5 was collected
Measured: 24 months
Duration of an MR4.0 and MR4.5
Duration of an MR4.0 and MR4.5 was collected
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
Patient-reported QoL
The EORTC QLQ-C30 questionnaire in conjunction with the EORTC QLQ-CML24 module was used to assess patient-reported QoL.
Measured: 24 months
Patient adherence
Patient adherence was documented using the MMAS-8 (Morisky et al., 2008) patient questionnaire.
Measured: 24 months
Proportion of patients who discontinue Tyrosine kinase inhibitor (TKI) therapy
Proportion of patients who discontinue Tyrosine kinase inhibitor (TKI) therapy was documented
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start28 Jun 2016
- Primary completion8 Sep 2022
- Study completion8 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734053
- Sponsor's protocol ID
- CAMN107ADE23
- Acronym
- NOFRETETE
- Status last verified
- Aug 2023
- First submitted
- 9 Feb 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05734053
- Acronym / sponsor ID
- NOFRETETE / CAMN107ADE23
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- Chronic myeloid leukemia, CML, NOFRETETE, Nilotinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2016 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nilotinib | – | Other: Nilotinibpatients prescribed with nilotinib in routine medical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male and female patients with diagnosed Philadelphia chromosome positive (Ph+) and/or Breakpoint cluster region-Abelson tyrosine kinase (Abelson murine leukemia proto-oncogene)+ Chronic myeloid leukemia who were being treated with nilotinib in first or any subsequent line and for whom treatment with nilotinib was indicated according to SmPC
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NilotinibAlso: TasignaThere was no treatment allocation. Patients administered Nilotinib by prescription could be enrolled. | Other | Nilotinib |
Primary outcome
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
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
Duration of an MR4.0 and MR4.5
Time frame: 24 months
Duration of an MR4.0 and MR4.5 was collected
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
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
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.
Patient adherence
Time frame: 24 months
Patient adherence was documented using the MMAS-8 (Morisky et al., 2008) patient questionnaire.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Results for Study CAMN107ADE23 that is getting linked from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
77 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia, run by Novartis Pharmaceuticals at 77 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.