Clinical trial NCT06092879: Asciminib Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML- CP in Real World Setting in France
Official title: Scemblix® (Asciminib): Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML-CP in Real World Setting in France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Myeloid Leukemia
Keywords: Chronic myeloid leukemia
CML
asciminib
France
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors

Brief 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

Eligibility 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.

Primary outcomes:
measure: Proportion of patients remaining on asciminib at 12 months
timeFrame: Month 12
Secondary outcomes:
measure: Proportion of patients in major molecular response (MMR) - for patients not in MMR at treatment initiation
timeFrame: 12 months
measure: Proportion of patients in MMR - for patients in MMR at treatment initiation
timeFrame: 12 months
measure: Proportion of patients in MR2, MMR, MR4.0, MR4.5, uMR4.5 - for all patients
timeFrame: 3 months, 6 months, 9 months, 12 months and 15 months
measure: BCR::ABL1 on the International Scale (IS) kinetics along treatment - for all patients
timeFrame: 15 months
measure: Time to MMR from the index date - for patients not in MMR at treatment initiation
timeFrame: Up to 15 months
measure: Time from the first MMR to the first loss of MMR - for patients not in MMR at treatment initiation
timeFrame: Up to 15 months
measure: Event-Free Surviva (EFS)
timeFrame: Up to 15 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to 15 months
measure: Comorbidity profile
timeFrame: Baseline
measure: Disease characteristics
timeFrame: Baseline
measure: History of TKI treatment
timeFrame: Baseline
measure: Management of patients in real-life
timeFrame: 15 months
measure: Exposure patterns to asciminib
timeFrame: 15 months
measure: EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30)
timeFrame: Baseline, 3months, 6months, 9months, 12months, 15months
measure: EORTC QLQ-CML24 questionnaire
timeFrame: Baseline, 3months, 6months, 9months, 12months, 15months
measure: Emergence of mutations
timeFrame: Up to 15 months
measure: Proportion of patient with an AE described during asciminib treatment among patient reporting the same AE which led to discontinuation with previous TKI treatments
timeFrame: Up to 15 months
Other outcomes:
Locations:
city: Saint Priest en Jarez
country: France
facility: Novartis Investigative Site
state: Loire
city: Aix en Provence
country: France
facility: Novartis Investigative Site
city: Amiens
country: France
facility: Novartis Investigative Site
city: Angers Cedex 9
country: France
facility: Novartis Investigative Site
city: Antibes
country: France
facility: Novartis Investigative Site
city: Avignon
country: France
facility: Novartis Investigative Site
city: Besancon Cedex
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Brest
country: France
facility: Novartis Investigative Site
city: Brive La Gaillarde
country: France
facility: Novartis Investigative Site
city: Caen
country: France
facility: Novartis Investigative Site
city: Cagnes Sur Mer
country: France
facility: Novartis Investigative Site
city: Cannes
country: France
facility: Novartis Investigative Site
city: Challes Les Eaux
country: France
facility: Novartis Investigative Site
city: Dunkerque
country: France
facility: Novartis Investigative Site
city: Grenoble
country: France
facility: Novartis Investigative Site
city: Le Mans
country: France
facility: Novartis Investigative Site
city: Lens
country: France
facility: Novartis Investigative Site
city: Libourne
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Mulhouse cedex
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Nimes
country: France
facility: Novartis Investigative Site
city: Orleans
country: France
facility: Novartis Investigative Site
city: Perigueux
country: France
facility: Novartis Investigative Site
city: Quimper
country: France
facility: Novartis Investigative Site
city: Rennes
country: France
facility: Novartis Investigative Site
city: ST Malo Cedex
country: France
facility: Novartis Investigative Site
city: Strasbourg cedex
country: France
facility: Novartis Investigative Site
city: Tarbes
country: France
facility: Novartis Investigative Site
city: Tours
country: France
facility: Novartis Investigative Site
city: Trevenans
country: France
facility: Novartis Investigative Site
city: Troyes
country: France
facility: Novartis Investigative Site
city: Valence Cedex 9
country: France
facility: Novartis Investigative Site
city: Vesoul
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: