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

NCT ID: NCT05619978

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-03
• Study Completion Date: 2021-10-29

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

3L+ Cohort

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

3L Therapy

Intervention Type: OTHER

Treatments received in 3L were dasatinib, nilotinib, imatinib, ponatinib, bosutinib, and allo-SCT

T315I cohort

Patients with chronic myeloid leukemia with T315I mutation

T315I

Intervention Type: OTHER

Patients with chronic myeloid leukemia with T315I mutation

Interventions

3L Therapy

Treatments received in 3L were dasatinib, nilotinib, imatinib, ponatinib, bosutinib, and allo-SCT

Intervention Type: OTHER

T315I

Patients with chronic myeloid leukemia with T315I mutation

Intervention Type: OTHER

Other Intervention Names

third-line treatment

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Lyon, , France

Countries

France

Other Identifiers

CABL001A0FR01

Identifier Type: -

Identifier Source: org_study_id