Observational study on the effectiveness of asciminib for chronic myelogenous leukemia in Saudi Arabia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the real-world effectiveness, tolerability, adherence, healthcare resource utilization, and patient-reported outcomes of asciminib in patients with Ph+ Chronic Myelogenous Leukemia in chronic phase who have previously been treated with at least two tyrosine kinase inhibitors. The study will enroll approximately 40 patients over a 6-month period from six centers in Saudi Arabia, following them for 12 months. Data will be collected from electronic medical records, and the decision to prescribe asciminib will be made independently by physicians.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novartis Investigative Site
  Dammam, Saudi Arabia Recruiting
• Novartis Investigative Site
  Jeddah, Saudi Arabia Recruiting
• Novartis Investigative Site
  Riyadh, Saudi Arabia Recruiting
• Novartis Investigative Site
  Riyadh, Saudi Arabia Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Asciminib for chronic phase CML with T315I mutation

  This study tests asciminib 200 mg twice daily in adults with chronic phase CML and a T315I mutation after stem cell transplant to see if it helps control leukemia.

  Recruiting at 5 sites Phase 2 University of Jena · Aachen and 9 other locations · NCT07789574

• Asciminib for Ph+ CML-CP in Germany: real-world patient experiences

  This real-world study tests how asciminib performs in adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, including those newly diagnosed or after one prior TKI.

  Recruiting at 74 sites Novartis · Baden-Baden, Baden-Wurttemberg and 73 other locations · NCT07549516

• Asciminib in children and young adults with relapsed or refractory Ph+ or ABL-class Ph-like ALL

  This study tests asciminib in kids and young adults with relapsed or refractory Philadelphia-positive or ABL-class Ph-like ALL to see if it is safe and helps treat the leukemia.

  Recruiting at 4 sites Phase 1/2 Novartis · Sydney, New South Wales and 3 other locations · NCT07387926

• Scemblix (asciminib) for newly diagnosed chronic-phase CML in China

  This project will try asciminib (Scemblix) in adults newly diagnosed with chronic-phase CML to see if it controls the disease and is safe.

  Recruiting Novartis · Wuhan, Hubei · NCT07375355

• Asciminib for children and teens with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase

  This study will try asciminib as a treatment for children aged 1 to under 18 with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase, including newly diagnosed patients and those who are resistant or intolerant to prior TKIs, with or without the T315I mutation.

  Recruiting at 39 sites Phase 2 Novartis · Chicago, Illinois and 38 other locations · NCT07354074

• Asciminib maintenance after alloHCT or CAR T for adults with Ph+ ALL

  Doctors will try asciminib in adults with Ph+ ALL who are in remission after an allogeneic stem cell transplant or CAR T therapy to check safety and find the best dose to help prevent relapse.

  Recruiting Phase 1 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT07250087

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.