NCT05619978

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

A retrospective multi-center cohort study design was used to address the study objectives, using medical records obtained from three clinical centers in France.

Detailed description

The index date for patients in the 3L cohort was defined as the date of initiation of 3L therapy. The index date for the T315I cohort was defined as the date of treatment initiation with TKI or allogeneic stem cell transplantation (allo-SCT) after identification of T315I mutation status. The baseline (i.e., pre-index) period was defined as the 6 months prior to the index date, and the post-index period was defined as the time from the index date to the date of last patient contact or patient death. Patients who were alive at the end of the follow-up period were censored at the date of last contact.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
OTHER	3L Therapy	Treatments received in 3L were dasatinib, nilotinib, imatinib, ponatinib, bosutinib, and allo-SCT
OTHER	T315I	Patients with chronic myeloid leukemia with T315I mutation

Timeline

• Start date: 2021-05-03
• Primary completion: 2021-10-29
• Completion: 2021-10-29
• First posted: 2022-11-17
• Last updated: 2022-11-17

Locations

1 site across 1 country: France