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Taking people in Saudi ArabiaNo phase

Follows adults with chronic myeloid leukemia treated with asciminib after two prior drugs

Observes asciminib use in adults with chronic myeloid leukemia in routine care.

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Dammam, Jeddah, and Riyadh, Saudi ArabiaSee the 3 sites
Trial code
Registry title
RWE,NIS,Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib in Saudi Arabia. (ASC4REAL)
Status
Recruiting
People taking part
40 people, planned
Started
24 Mar 2025
Expected to end
30 Dec 2026
Type of study
Observational
Treatments tested
  • asciminib
Record updated
23 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Ph+ chronic myelogenous leukemia in chronic phase who have already had at least 2 TKI drugs and are now taking asciminib as part of routine care.

Age
18 Years to 99 Years
Sex
All sexes can join.
Disease stage
Ph+ chronic myelogenous leukemia in chronic phase (CML-CP), with <15% blasts in blood and bone marrow, <30% blasts plus promyelocytes, <20% basophils in blood, and ≥50 x 109/L platelets.
Earlier treatment
Must have had at least 2 earlier TKIs (such as imatinib, dasatinib, nilotinib, bosutinib or ponatinib). Must now be taking asciminib, started no more than 6 months before joining.
Biomarker or test result
Ph+ (Philadelphia chromosome positive) leukemia.

Main reasons for not taking part

  • Asciminib given as first or second treatment
  • Taking part in another clinical trial
  • Did not sign the informed consent form
  • Investigator thinks the person cannot give an accurate medical history or long-term follow-up

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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
  • 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 take part

  • 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
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 99 years old?

Where in Saudi Arabia

  • DammamHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
  • JeddahHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
  • RiyadhHospital not named in the registryContact: Novartis PharmaceuticalsTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Asciminib

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Follows adults with chronic myeloid leukemia treated with asciminib after two prior drugsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06684964, who can take part
Record updated
23 December 2025