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

Phase

N/A

Condition

Platelet Disorders

Chronic Myeloid Leukemia

Leukemia

Treatment

N/A

Clinical Study ID

NCT05619978

CABL001A0FR01

Ages 18-99
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 failingon ≥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 orallo-SCT

Exclusion

Exclusion Criteria:

History of other active malignancies within the 3 years prior to the time of CML-CPdiagnosis
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 ofT315I mutation
Enrollment in a clinical trial at the time of 3L therapy initiation or at the time oftreatment initiation after identification of T315I mutation

Study Design

May 03, 2021

October 29, 2021

Study 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.

Connect with a study center

Novartis Investigative Site
Lyon,
France
Site Not Available

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