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Trial Title:
Asciminib Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML- CP in Real World Setting in France
NCT ID:
NCT06092879
Condition:
Chronic Myeloid Leukemia
Conditions: Official terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Asciminib
Conditions: Keywords:
Chronic myeloid leukemia
CML
asciminib
France
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Asciminib
Description:
There is no treatment allocation. Patients administered Asciminib by prescription will be
enrolled
Arm group label:
Asciminib
Other name:
Scemblix
Summary:
The purpose of this study is to enhance the knowledge on asciminib treatment in a broader
and real-life population by collecting additional data to characterize the treatment
patterns of patients treated with asciminib, with a primary objective represented by
maintenance on treatment at 12 months.
Detailed description:
The ASSURE-3 study is a national, multicentric, non-interventional, prospective study in
real-life conditions with primary data collection in adult patients with Philadelphia
chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously
treated with two or more Tyrosine Kinase Inhibitors (TKIs). It will be conducted in
France with hematologists, onco-hematologists, physicians with documented involvement in
managing Ph+ CML-CP patients in routine practice, practicing in public or private health
care institutions. Each patient will be followed during 15 months at M0, M1 and then
every 3 months (rhythm of visits according to the routine clinical care), or until
premature discontinuation of asciminib treatment.
Historical data will be abstracted retrospectively by the participating physicians from
patient files, to collect information using an electronic case report form (eCRF).
Primary data will be collected during inclusion and follow-up visits
Criteria for eligibility:
Study pop:
Adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic
phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Patient aged ≥ 18 years at inclusion,
2. Patient with Ph+ CML-CP previously treated with two or more TKIs,
3. Patient for whom a decision has been taken by the treating physician (investigator)
to initiate treatment with asciminib according to his own practice, the drug label /
Summary of Product Characteristics (SmPC), and regardless of study participation,
4. Patient having given their non objection to participate to the study
Exclusion Criteria:
1. Patient with CML in accelerated phase (AP) or blastic phase (BP) at enrolment,
2. Patient with known history of T315I mutation,
3. Patient who previously received asciminib treatment,
4. Patient currently participating to an interventional clinical trial,
5. Patient with known contra-indication to asciminib according to the SmPC.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Novartis Investigative Site
Address:
City:
Avignon cedex 9
Zip:
84902
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Montpellier
Zip:
34070
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Mulhouse cedex
Zip:
68070
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
RENNES Cedex 9
Zip:
35033
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Strasbourg cedex
Zip:
67085
Country:
France
Status:
Recruiting
Start date:
March 6, 2024
Completion date:
December 15, 2026
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06092879
