Clinical trial · Observational
French Study to Highlight the Unmet Treatment Needs of 3L+ CP-CML and With T315I-mutated CML Patients
A Multi-Center Retrospective Chart Review Study Examining the Patient Characteristics, Treatment Patterns, Clinical Outcomes, and Burden of Illness Among Patients With Chronic Myeloid Leukemia in Third-line Treatment or With T315I Mutation in France (CML 3L+ & T315I)
NCT05619978CI-TRIAL-00062221completedClinicalTrials.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)
A retrospective multi-center cohort study design was used to address the study objectives, using medical records obtained from three clinical centers in France.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3L Therapy | Other | — | UNRESOLVED |
| T315I | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 3L+ Cohort
- description
- Patients who initiated third-line treatment (3L) therapy. Treatments received in 3L were dasatinib, nilotinib, imatinib, ponatinib, bosutinib, and allo-SCT
- interventionNames
- Other: 3L Therapy
- label
- T315I cohort
- description
- Patients with chronic myeloid leukemia with T315I mutation
- interventionNames
- Other: T315I
Primary outcomes (19)
- measure
- Number of patients: Year patient initiated third-line treatment
- timeFrame
- throughout the study (study used data from 2000 to 2021)
- description
- Following categories included: Before 2010 2010-2014 2015-2019 2020-2021
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with CML-CP * Age ≥18 years at the time of CML-CP diagnosis * For 3L patients: initiated one of the following 3L therapies in CML-CP after failing on ≥2 TKIs (i.e., bosutinib, dasatinib, imatinib, nilotinib, or ponatinib) or allo-SCT * For T315I mutation patients: evidence of T315I mutation and treatment with TKI or allo-SCT Exclusion Criteria: * History of other active malignancies within the 3 years prior to the time of CML-CP diagnosis * Documentation of anti-cancer therapies for any other malignancies prior to the time of 3L therapy initiation or at the time of treatment initiation after identification of T315I mutation * Enrollment in a clinical trial at the time of 3L therapy initiation or at the time of treatment initiation after identification of T315I mutation
References
Publications (0)
Data not yet available
No reference posted for this study.