Clinical trial · Observational
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.
NCT05734053CI-TRIAL-00068926NOFRETETEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nilotinib | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Nilotinib
- description
- patients prescribed with nilotinib in routine medical practice
- interventionNames
- Other: Nilotinib
Primary outcomes (8)
- measure
- Proportion of patients in Major molecular response (MMR), and Deep molecular response according to international standard (MR^4.0 and MR^4.5)
- timeFrame
- 24 months
- description
- Proportion of patients in MMR, MR\^4.0 and MR\^4.5 was collected
- measure
- Time to achievement of an MR4.0 and MR4.5
- timeFrame
- 24 months
- description
- Time to achievement of an MR4.0 and MR4.5 was collected
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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,
References
Publications (0)
Data not yet available
No reference posted for this study.