Clinical trial · Observational
Observational Study on CML Patients in Any Phase of the Disease Treated With Ponatinib (Iclusig®)
Observational Study on CML Patients in Any Phase of the Disease Treated With Ponatinib (Iclusig®): A Multicentre, Ambispective Cohort Study
NCT04048564CI-TRIAL-00069998completedClinicalTrials.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 is a multicentre ambispective cohort study involving French patients who have started or are receiving for less than 6 months a treatment with ponatinib. This study aims at better qualifying the ponatinib benefit-risk balance in real life and in relation with CML patients' therapeutic history.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- For participants in chronic myeloid leukemia in chronic (CP-CML) phase: Proportion of participants who achieve a major molecular response after the initiation of study treatment
- timeFrame
- from 24-60 months
- description
- Chronic myeloid leukemia (CML) response criteria as defined by the European LeukemiaNet Recommendations for Management of Chronic Myeloid Leukemia (Hochhaus et al Leukemia 2020).
- measure
- For participants in chronic myeloid leukemia in accelerated phase (AP-CML) or chronic myeloid leukemia in blast phase (BP-CML): Proportion of participants who achieve a complete hematologic response
- timeFrame
- from 24-60 months
- description
- CML response criteria as defined by the European LeukemiaNet Recommendations for Management of Chronic Myeloid Leukemia.
Secondary outcomes (14)
- measure
- Proportion of participants in CP-CML phase who achieved complete hematologic response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Presenting a CML in any phase. * Having initiated for less than six months a treatment with ponatinib. * The ability to understand the requirements of the study and to comply with the study data collection procedures. Exclusion Criteria: * Patients previously treated with investigational ponatinib (within a clinical trial). * Patients receiving an investigational agent. * Patients who are pregnant and/or breastfeeding. * Patients with contraindications for Ponatinib according to Summary of Products Characteristics.
References
Publications (1)
- DERIVEDHuguet F, Guerci-Bresler A, Roth-Guepin G, Cayssials E, Slama B, Santagostino A, Penot A, Quittet P, Cony-Makhoul P, Saad A, Bastie JN, Hacini M, Coiteux V, Uzunov M, Roy L, Le Clech L, Berger M, Agneray AM, Messas E, Etienne G, Turhan A, Nicolini FE, Rousselot P. Clinical outcomes in patients in any phase of CML treated with ponatinib in France-Data from the TOPASE observational study. Br J Haematol. 2024 Dec;205(6):2295-2304. doi: 10.1111/bjh.19819. Epub 2024 Nov 6. PMID 39506529