Chronic Myelogenous Leukemia in Chronic PhaseASC4REALNCT06684964
RWE,NIS,Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib in Saudi Arabia. (ASC4REAL)
An observational study of Chronic Myelogenous Leukemia in Chronic Phase, run by Novartis Pharmaceuticals at 4 sites in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Myelogenous Leukemia in Chronic Phase
- What is being tested?
- asciminib
- How many people
- 40 participants
- Where
- 4 sitesSaudi Arabia
- Study dates
- 24 Mar 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients eligible for inclusion in this study must meet all the following criteria:
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
Saudi Arabia4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Dammam, 15215
- Recruiting
Novartis Investigative Site
Jeddah, 21423
- Recruiting
Novartis Investigative Site
Riyadh, 11211
- Recruiting
Novartis Investigative Site
Riyadh, 11426
About this study
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)
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.
Read the 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.
- Being tested
- asciminib
- Keywords
- Chronic Myelogenous Leukemia in chronic phase, CML-CP, Asciminib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asciminibOther
This is an observational study. There is no treatment allocation. The decision to initiate asciminib will be based solely on clinical judgement.
| Study group | Role | What they receive |
|---|---|---|
| Asciminib | Patients who have been receiving asciminib for up to 6 months prior to study start Receives: Other: asciminib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 12
Secondary outcomes (6)
Frequency and severity of hematologic and non-hematologic AEs
Frequency and severity of hematologic and non-hematologic AEs
Measured: Up to 12 months
Major Molecular Response (MMR) Rate
MMR is defined as a BCR-ABL1 transcript level ≤0.1%.
Measured: Baseline, month 6, month 12
Deep Molecular Response (DMR) Rate
Percentage of participants with MR4.0 and MR4.5:
- MR4.0 [ BCR-ABL1 transcript level ≤0.01%]
- MR4.5 [ BCR-ABL1 transcript level ≤0.0032%]
Measured: Month 6, month 12
Cytogenetic Response (CCyR) Rate
Assessment of CCyR and/or [BCR-ABL1 transcript level ≤1%]
Measured: Month 6, month 12
Duration of MMR
Assess the duration of MMR in participants.
Measured: Up to 12 months
Simplified Medication Adherence Questionnaire (SMAQ) score.
SMAQ assesses adherence to medication. It is a 6-item questionnaire that evaluates different aspects of patient compliance with treatment: forgetfulness, routine, adverse effects, and omissions. A patient is classified as non-compliant if he/she responds to any of the questions with a non-adherence answer, and in terms of quantification, if the patient has lost more than two doses during the last week or has not taken medication during more than two complete days during the last three months.
Measured: Month 6, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start24 Mar 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous Leukemia in Chronic PhaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684964
- Sponsor's protocol ID
- CABL001ASA01
- Acronym
- ASC4REAL
- Status last verified
- Dec 2025
- First submitted
- 11 Nov 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06684964
- Acronym / sponsor ID
- ASC4REAL / CABL001ASA01
- Keywords
- Chronic Myelogenous Leukemia in chronic phase, CML-CP, Asciminib
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asciminib | – | Other: asciminibPatients who have been receiving asciminib for up to 6 months prior to study start |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| asciminibThis is an observational study. There is no treatment allocation. The decision to initiate asciminib will be based solely on clinical judgement. | Other | Asciminib |
Primary outcome
Major molecular response (MMR)
Time frame: Month 12
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.
6 secondary outcomes
Frequency and severity of hematologic and non-hematologic AEs
Time frame: Up to 12 months
Major Molecular Response (MMR) Rate
Time frame: Baseline, month 6, month 12
Deep Molecular Response (DMR) Rate
Time frame: Month 6, month 12
Cytogenetic Response (CCyR) Rate
Time frame: Month 6, month 12
Duration of MMR
Time frame: Up to 12 months
Simplified Medication Adherence Questionnaire (SMAQ) score.
Time frame: Month 6, month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myelogenous Leukemia in Chronic Phase, run by Novartis Pharmaceuticals at 4 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major molecular response (MMR) (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.