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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06092879
Other study ID # CABL001AFR04
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 6, 2024
Est. completion date December 15, 2026

Study information

Verified date May 2024
Source Novartis
Contact Novartis Pharmaceuticals
Phone +41613241111
Email novartis.email@novartis.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 168
Est. completion date December 15, 2026
Est. primary completion date December 15, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Asciminib
There is no treatment allocation. Patients administered Asciminib by prescription will be enrolled

Locations

Country Name City State
France Novartis Investigative Site Bordeaux
France Novartis Investigative Site Mulhouse cedex

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients remaining on asciminib at 12 months Proportion of patients remaining on asciminib treatment at 12 months to be provided Month 12
Secondary Proportion of patients in major molecular response (MMR) - for patients not in MMR at treatment initiation Molecular response to treatment: Response to treatment (MMR, BCR::ABL1 = 0.1% on the International Scale, IS) at 12 months (+/- 1 month) for patients not in MMR at treatment initiation 12 months
Secondary Proportion of patients in MMR - for patients in MMR at treatment initiation Molecular response to treatment: Maintenance of molecular response (MMR, BCR::ABL1 = 0.1% on the International Scale, IS) at 12 months (+/- 1 month) for patients in MMR at treatment initiation 12 months
Secondary Proportion of patients in MR2, MMR, MR4.0, MR4.5, uMR4.5 - for all patients Molecular response to treatment: Kinetics of response: MR2, MMR, MR4.0, MR4.5, undetectable MR4.5 for all patients.
MR2, MR4, MR4.5 are defined as the transcript ratio of BCR-ABL1/ABL1 being 1% or less, 0.01% or less and 0.0032% or less respectively
3 months, 6 months, 9 months, 12 months and 15 months
Secondary BCR::ABL1 on the International Scale (IS) kinetics along treatment - for all patients Kinetics of response: BCR::ABL1 on the International Scale (IS) for all patients 15 months
Secondary Time to MMR from the index date - for patients not in MMR at treatment initiation Kinetics of response: Time to MMR for patients not in MMR at treatment initiation Up to 15 months
Secondary Time from the first MMR to the first loss of MMR - for patients not in MMR at treatment initiation Molecular response to treatment: Duration of MMR for patients not in MMR at treatment initiation Up to 15 months
Secondary Event-Free Surviva (EFS) EFS: time from index date to occurrence of one the events listed among variables:
lack of efficacy, i.e., BRC::ABL1>1% or loss of CCyR if assessed
disease progression (CML-AP/BP, CML death)
death from any cause
definitive treatment discontinuation due to any reason
Up to 15 months
Secondary Progression-Free Survival (PFS) PFS: time from index date to occurrence of one of the progression markers listed among variables:
disease progression (CML-AP/BP, CML death),
death from any cause,
definitive treatment discontinuation due to any reason
Up to 15 months
Secondary Comorbidity profile Charlson comorbidity index (CCI) at index date Baseline
Secondary Disease characteristics Disease characteristics to be provided Baseline
Secondary History of TKI treatment History of TKI treatment to be provided Baseline
Secondary Management of patients in real-life Concomitant medications 15 months
Secondary Exposure patterns to asciminib Exposure patterns to be provided 15 months
Secondary EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30) The EORTC QLQ-C30 contains 30 questions assessed by the participant. There are 9 multiple-item scales: 5 scales that assess aspects of functioning (physical, role functioning, cognitive, emotional, and social); 3 symptom scales (Fatigue, Pain, and Nausea and Vomiting); and a global health status/Quality of Life (QOL) scale. There are 5 single-item measures assessing additional symptoms (i.e., dyspnea, loss of appetite, insomnia, constipation, and diarrhea) and a single item concerning perceived financial impact of the disease. All but two questions have 4-point scales ranging from "Not at all" to "Very much." The two questions concerning global health status/ QOL have 7 point scales with ratings ranging from "Very poor" to "Excellent." For each of the 14 domains, final scores are transformed such that they range from 0-100, where higher scores indicate improvement. Baseline, 3months, 6months, 9months, 12months, 15months
Secondary EORTC QLQ-CML24 questionnaire The EORTC QLQ-CML24 was designed to supplement the QLQ-C30 - the QLQ-CML24 is not a stand-alone instrument but is to be used in conjunction with the QLQ-C30.
The EORTC QLQ-CML 24 is composed of four multi-item scales and two single-item scales. The module consists of 24 items assessing symptoms burden (13 items), impact on worry/mood (4 items), impact on daily life (3 items), satisfaction with care and information (2 items) body image problems (1 item) and satisfaction with social life (1 item). The items were measured on four levels: 1=not at all, 2=a little, 3=quite a bit, 4=very much. For each domain, scores were averaged and transformed to 0 to 100. A higher score in satisfaction with social life domain indicates a higher level of satisfaction. A positive change from baseline indicates increasing satisfaction.
Baseline, 3months, 6months, 9months, 12months, 15months
Secondary Emergence of mutations If available at end of treatment: mutational analysis, methods and results Up to 15 months
Secondary Proportion of patient with an AE described during asciminib treatment among patient reporting the same AE which led to discontinuation with previous TKI treatments Cross intolerance with previous TKI treatments Up to 15 months
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