Clinical trial · Observational
Front-line Nilotinib Treatment of BCR-ABL+ Chronic Myeloid Leukaemia in Chronic Phase
Front-line Nilotinib Treatment of BCR-ABL+ Chronic Myeloid Leukaemia in Chronic Phase. An Observational Multicentre Study of the GIMEMA CML WP.
NCT01699217CI-TRIAL-00088683CML0912completedClinicalTrials.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)
The GIMEMA CML Working Party promotes a multicentre, observational, prospective study of CML patients treated frontline with NIL. Patients will be followed for 5 years. This study will help the definition of guidelines for the treatment of CML patients in early CP.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BCR-ABL Positive | — | UNRESOLVED | — |
| Chronic Myeloid Leukaemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Chronic Phase Philadelphia Positive | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The rate of confirmed MR4
- timeFrame
- At 24 months from study entry
Secondary outcomes (10)
- measure
- The rate of MMR
- timeFrame
- At 24, 36, 48, and 60 months from study entry.
- measure
- The rate of MR4
- timeFrame
- At 24, 36, 48, and 60 months from study entry.
- measure
- The rate of MR4.5
- timeFrame
- At 24, 36, 48, and 60 months from study entry.
- measure
- The rate of confirmed MR4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age: \>=18 years; * Patients with chronic phase Ph+ and/or BCR-ABL+ CML, newly diagnosed (less than 6 months); * Prior treatment with Hydroxyurea or Anagrelide is allowed; * Prior treatment with IM for less than 30 days is allowed; * Signed written informed const according to ICH/EU/GCP and national local laws. Exclusion Criteria: * Patients who are pregnant (negative pregnancy test is requested within 2 days before nilotinib start) or breast feeding, or adults of reproductive potential not employing an effective method of birth control. * Newly diagnosed Ph+ and/or BCR-ABL+ CML patients in advanced phases (accelerated or blastic phase). * Prior treatment with nilotinib, dasatinib, or other tyrosine-kinase inhibitors.
References
Publications (0)
Data not yet available
No reference posted for this study.