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

NCT05619978 | Completed

• 1 other identifier: CABL001A0FR01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myeloid Leukemia

Keywords

BCR::ABL,; Chronic myeloid leukemia,; Tyrosine kinase inhibitor,; T315I mutation

Outcome Measures

Primary Outcomes (19)

• Number of patients: Year patient initiated third-line treatment

  Following categories included: Before 2010 2010-2014 2015-2019 2020-2021

  throughout the study (study used data from 2000 to 2021)

• Duration of third-line treatment

  Duration of third-line treatment was reported

  throughout the study (study used data from 2000 to 2021)

• Number of patients: Type of therapy received in third-line treatment

  * TKI agent * Allo-SCT

  throughout the study (study used data from 2000 to 2021)

• Time from 2L discontinuation to third-line treatment initiation

  Time from 2L discontinuation to third-line treatment initiation was reported

  throughout the study (study used data from 2000 to 2021)

• Number of patients still on 3L therapy as of data collection date

  Number of patients still on 3L therapy as of data collection date was reported

  throughout the study (study used data from 2000 to 2021)

• Number of patients discontinued 3L

  Number of patients who discontinued 3L treatment were reported

  throughout the study (study used data from 2000 to 2021)

• Number of patients: Reasons for 3L discontinuation

  * Treatment switch due to AEs or intolerance * Treatment switch due to resistance * Treatment switch due to signs of ineffectiveness * Treatment switch due to other reasons

  throughout the study (study used data from 2000 to 2021)

• Number of lines of therapy for patients with chronic myeloid leukemia in third-line treatment

  Number of lines of therapy for patients with chronic myeloid leukemia in third-line treatment were reported

  throughout the study (study used data from 2000 to 2021)

• Number of most frequent treatment sequences for patients with chronic myeloid leukemia in third-line treatment

  Number of most frequent treatment sequences for patients with chronic myeloid leukemia in third-line treatment were reported

  throughout the study (study used data from 2000 to 2021)

• Number of last line of therapy for patients with chronic myeloid leukemia in third-line treatment

  Number of last line of therapy for patients with chronic myeloid leukemia in third-line treatment were reported

  throughout the study (study used data from 2000 to 2021)

• Number of patients: Year patient initiated on the line identified as T315I line of interest

  Following categories included: Before 2010 2010-2014 2015-2019

  throughout the study (study used data from 2000 to 2021)

• Duration of the line identified as T315I line of interest

  Duration of the line identified as T315I line of interest was reported

  throughout the study (study used data from 2000 to 2021)

• Number of patients: Type of therapy received in the line identified as T315I line of interest

  * TKI agent * Allo-SCT

  throughout the study (study used data from 2000 to 2021)

• Number of patients still on line of therapy identified as T315I line of interest as of data collection date

  Number of patients still on line of therapy identified as T315I line of interest as of data collection date were reported

  throughout the study (study used data from 2000 to 2021)

• Number of patients: Reasons for discontinuation on the line identified as T315I line of interest

  * Adverse events or intolerance * Resistance * Signs of ineffectiveness Suboptimal response Progression to accelerated phase or blast phase * Other reasons Acquired mutations

  throughout the study (study used data from 2000 to 2021)

• Number of lines of therapy for patients with chronic myeloid leukemia with T315I mutation

  Number of lines of therapy for patients with chronic myeloid leukemia with T315I mutation were reported

  throughout the study (study used data from 2000 to 2021)

• Number of line identified as T315I line of interest

  Number of line identified as T315I line of interest were reported

  throughout the study (study used data from 2000 to 2021)

• Number of treatment sequence for patients with chronic myeloid leukemia with T315I mutation

  Number of treatment sequence for patients with chronic myeloid leukemia with T315I mutation were reported

  throughout the study (study used data from 2000 to 2021)

• Number of last line of therapy for patients with chronic myeloid leukemia with T315I mutation

  Number of last line of therapy for patients with chronic myeloid leukemia with T315I mutation were reported

  throughout the study (study used data from 2000 to 2021)

Secondary Outcomes (40)

• Cytogenetic response (CyR) for 3L patients

  12 and 24 months

• Proportion of patients achieving response among patients with chronic myeloid leukemia in third-line treatment in 12 months

  12 months post treatment

• Proportion of patients achieving response among patients with chronic myeloid leukemia in third-line treatment in 24 months

  24 months post treatment

• Proportion of patients achieving sustained molecular responses among patients with chronic myeloid leukemia in third-line treatment in 12 months

  12 months post treatment

• Proportion of patients achieving sustained molecular responses among patients with chronic myeloid leukemia in third-line treatment in 24 months

  24 months post treatment

Study Arms (2)

3L+ Cohort

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

Other: 3L Therapy

T315I cohort

Patients with chronic myeloid leukemia with T315I mutation

Other: T315I

Interventions

3L Therapy OTHER

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

Also known as: third-line treatment

3L+ Cohort

T315I OTHER

Patients with chronic myeloid leukemia with T315I mutation

T315I cohort

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included CML-CP patients (i.e., 3L patients and patients with T315I mutation) who met the eligibility criteria

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Lyon, France

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 17, 2022
• Study Start: May 3, 2021
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)