French Study to Highlight the Unmet Treatment Needs of 3L+ CP-CML and With T315I-mutated CML Patients

Novartis

Status: Completed

Conditions: Chronic Myeloid Leukemia

Treatments: Other: 3L Therapy; Other: T315I

Study type: Observational

Funder types: Industry

Identifiers

NCT05619978

CABL001A0FR01

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

3L+ Cohort

Description:

Patients who initiated third-line treatment (3L) therapy. Treatments received in 3L were dasatinib, nilotinib, imatinib, ponatinib, bosutinib, and allo-SCT

Treatment:

Other: 3L Therapy

T315I cohort

Description:

Patients with chronic myeloid leukemia with T315I mutation

Treatment:

Other: T315I