RWE,NIS,Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib in Saudi Arabia. (ASC4REAL)

NCT06684964 | Recruiting

• 1 other identifier: CABL001ASA01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Myelogenous Leukemia in Chronic Phase

Keywords

Chronic Myelogenous Leukemia in chronic phase; CML-CP; Asciminib

Outcome Measures

Primary Outcomes (1)

• Major molecular response (MMR)

  MMR is defined as a breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 protein (BCR-ABL1) transcript level ≤0.1%, at 12 months.

  Month 12

Secondary Outcomes (6)

• Frequency and severity of hematologic and non-hematologic AEs

  Up to 12 months

• Major Molecular Response (MMR) Rate

  Baseline, month 6, month 12

• Deep Molecular Response (DMR) Rate

  Month 6, month 12

• Cytogenetic Response (CCyR) Rate

  Month 6, month 12

• Duration of MMR

  Up to 12 months

Study Arms (1)

Asciminib

Patients who have been receiving asciminib for up to 6 months prior to study start

Other: asciminib

Interventions

asciminib OTHER

This is an observational study. There is no treatment allocation. The decision to initiate asciminib will be based solely on clinical judgement.

Asciminib

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

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.

You may qualify if:

• Signed and dated Patient Informed Consent Form obtained.
• Male or female patients with a diagnosis of Ph+ CML-CP ≥18 years of age with the following laboratory values:
• \<15% blasts in peripheral blood and bone marrow
• \<30% blasts plus promyelocytes in peripheral blood and bone marrow
• \<20% basophils in the peripheral blood
• ≥50 x 109/L (≥50,000/mm3) platelets
• \. 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.

You may not qualify if:

• Patients meeting ANY of the following criteria are not eligible for participation:
• Asciminib based treatment regimen in first or second line.
• Patients are currently participating in any other clinical trials.
• Patients who refused to sign informed consent.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

Novartis Investigative Site

Dammam, 15215, Saudi Arabia

RECRUITING

Novartis Investigative Site

Jeddah, 21423, Saudi Arabia

RECRUITING

Novartis Investigative Site

Riyadh, 11211, Saudi Arabia

RECRUITING

Novartis Investigative Site

Riyadh, 11426, Saudi Arabia

RECRUITING

MeSH Terms

Interventions

asciminib

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

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

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: March 24, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (4)