Clinical trial NCT06684964: RWE,NIS,Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib in Saudi Arabia. (ASC4REAL)
Official title: Real-World Evidence Non-interventional Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib After Two Previous TKIs in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) in Saudi Arabia. (ASC4REAL)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Myelogenous Leukemia in Chronic Phase
Keywords: Chronic Myelogenous Leukemia in chronic phase
CML-CP
Asciminib
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 40
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: Patients must have been prescribed asciminib for a maximum of 6 months before enrolling in the study. Patients will be included in the study regardless of their MMR status at the initiation of asciminib treatment.

Brief summary: This is a non-interventional, prospective, observational single arm study describing the real-world effectiveness, tolerability, adherence, Healthcare Resource Utilization (HCRU) and Patient-Reported Outcome (PRO) data of asciminib in patients with Ph+ Chronic Myelogenous Leukemia - Chronic Phase (CML-CP) previously treated with ≥2 Tyrosine Kinase Inhibitor (TKIs) in routine clinical practice in Kingdom of Saudi Arabia.

Detailed description: Patients who have been receiving asciminib for up to 6 months prior to study start will be enrolled over a period of approximately 6 months and followed up for 12 months to assess study outcomes.

Each patient will be followed from baseline up to the earliest of death, loss to follow-up or end of the 12-month follow-up.

The study aims to enrol approximately 40 patients in a single arm design from a total of 6 centers in Kingdom of Saudi Arabia (KSA) over an enrollment period of approximately 6 months. These patients must have been prescribed asciminib for a maximum of 6 months before enrolling in the study. The prescription of asciminib should align with its approved label use. Importantly, the decision to prescribe asciminib to these patients should have been made independently by the physician and not influenced by the study. Data will be collected from patient electronic medical records in the sites chosen.

Eligibility criteria: Inclusion Criteria:

Patients eligible for inclusion in this study must meet all the following criteria:

1. Signed and dated Patient Informed Consent Form obtained.
2. Male or female patients with a diagnosis of Ph+ CML-CP ≥18 years of age with the following laboratory values:

   1. \<15% blasts in peripheral blood and bone marrow
   2. \<30% blasts plus promyelocytes in peripheral blood and bone marrow
   3. \<20% basophils in the peripheral blood
   4. ≥50 x 109/L (≥50,000/mm3) platelets

4. Prior treatment with a minimum of 2 prior TKIs: e. First-generation TKI imatinib f. 2G-TKI dasatinib, nilotinib and bosutinib g. 3G-TKI ponatinib 4. Patients are currently receiving asciminib as per approved local label and independently of study participation. Patients must have started asciminib therapy no more than 6 months prior to their enrollment in the study.

Exclusion Criteria:

Patients meeting ANY of the following criteria are not eligible for participation:

1. Asciminib based treatment regimen in first or second line.
2. Patients are currently participating in any other clinical trials.
3. Patients who refused to sign informed consent.
4. According to the investigator's opinion, the patient is an unlikely candidate to provide an accurate medical history and/or to obtain long-term follow-up information for any reasons such as unavailability or severe concomitant illnesses.

Primary outcomes:
measure: Major molecular response (MMR)
timeFrame: Month 12
Secondary outcomes:
measure: Frequency and severity of hematologic and non-hematologic AEs
timeFrame: Up to 12 months
measure: Major Molecular Response (MMR) Rate
timeFrame: Baseline, month 6, month 12
measure: Deep Molecular Response (DMR) Rate
timeFrame: Month 6, month 12
measure: Cytogenetic Response (CCyR) Rate
timeFrame: Month 6, month 12
measure: Duration of MMR
timeFrame: Up to 12 months
measure: Simplified Medication Adherence Questionnaire (SMAQ) score.
timeFrame: Month 6, month 12
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: