Study of Asciminib Treatment for Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase

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What is this study about?

This clinical trial focuses on patients with Chronic Myeloid Leukemia (CML) who have been newly diagnosed with the disease. The study evaluates a treatment using asciminib hydrochloride, a medication that works by targeting specific proteins involved in cancer cell growth. The medication is taken by mouth in the form of tablets, with a maximum daily dose of 80 mg.

The purpose of this research is to evaluate how well the combination of asciminib with other medications that target the same cancer-causing proteins works in achieving a deep reduction in cancer cells in patients who have not received previous treatment for their disease. The treatment period lasts for 21 days, and patients will be monitored to assess how their body responds to the medication.

The study involves regular medical check-ups to monitor the patient’s health status and response to treatment. Blood tests will be performed to measure the levels of cancer cells and to check how well the patient’s organs are functioning. The medication being studied is designed to specifically target the genetic change that causes this type of leukemia, known as the Philadelphia chromosome.

1 Initial diagnosis confirmation

Confirmation of Chronic Myeloid Leukemia (CML) diagnosis through cytogenetic testing

Verification of the presence of Philadelphia chromosome or BCR-ABL1 positive status

2 Medical evaluation

Assessment of general health condition and performance status

Laboratory tests including:

– Blood tests for liver function (AST, ALT)

– Kidney function test (serum creatinine)

– Electrolyte levels (potassium, magnesium, calcium)

– Lipase levels

– Total bilirubin

3 Treatment initiation

Beginning of treatment with asciminib

Medication will be taken by mouth (oral administration)

Treatment continues as part of the study until 2027

4 Response monitoring

Regular monitoring of molecular response to treatment

Key evaluation of treatment response at 12 months

Assessment of deep molecular response (MR4)

5 Ongoing assessments

Regular laboratory tests to monitor organ function

Continuous evaluation of treatment effectiveness

Monitoring for any side effects

Who Can Join the Study?

  • Must be at least 18 years old (no upper age limit)
  • Can be either male or female
  • Must have confirmed diagnosis of Chronic Myeloid Leukemia in chronic phase with specific genetic markers (Philadelphia chromosome positive or BCR-ABL1 positive)
  • Must have ECOG performance status of 2 or better (able to carry out most daily activities)
  • Must provide written informed consent before starting any study procedures
  • Blood tests must show:
    • Liver enzymes (AST and ALT) no more than 2.5 times above normal limit
    • Lipase levels no more than 1.5 times above normal limit
    • Normal levels of potassium, magnesium, and calcium
    • Total bilirubin no more than 1.5 times above normal (except for patients with Gilbert’s disease)
    • Creatinine levels no more than 2 times above normal limit
  • Alkaline phosphatase must be no more than 2.5 times above normal limit (unless related to leukemia)

Who Cannot Join the Study?

  • Prior treatment with any medication for Chronic Myeloid Leukemia (CML)
  • Known severe allergic reactions to similar medications
  • Presence of BCR-ABL1 mutations (genetic changes in blood cells)
  • Active or uncontrolled infections
  • Major surgery within 4 weeks before starting the study
  • Significant heart problems or irregular heart rhythm
  • Severe liver problems (impaired liver function)
  • Severe kidney problems (impaired kidney function)
  • Pregnant or breastfeeding women
  • Unable to swallow oral medications
  • Current participation in another clinical trial
  • Mental conditions that could interfere with study compliance
  • Any condition that the study doctor believes would make participation unsafe
  • History of other cancers within the past 3 years (except treated skin cancer)
  • Uncontrolled high blood pressure

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Gesundheit Nord gGmbH Klinikverbund Bremen Bremen Germany
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH Regensburg Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Philipps-Universitaet Marburg Marburg Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH Paderborn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Upvrrjmxgmyecgnunjlma Esdpi Asc Essen Germany
Grfspv Uqukefmvgp Fljkiqcll Frankfurt Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
23.07.2019

Trial locations

Investigated drugs:

Asciminib is a medication used to treat chronic myeloid leukemia (CML). It works by targeting and blocking specific proteins called BCR-ABL1 that cause the cancer cells to grow. This medication belongs to a class of drugs known as ATP-competitive inhibitors, which means it competes with ATP (a natural molecule in cells) to block cancer cell growth. It is used as a treatment for patients who have been newly diagnosed with CML.

Investigated diseases:

Chronic Myeloid Leukemia – A type of blood cancer that begins in the bone marrow when abnormal white blood cells start growing uncontrollably. The condition develops gradually, typically progressing through three phases: chronic, accelerated, and blast phase. In this disease, a genetic change creates an abnormal protein that causes the bone marrow to produce too many white blood cells. These abnormal cells build up in the bone marrow and spill into the bloodstream, but initially may cause few or no symptoms. Over time, the abnormal cells can crowd out healthy blood cells and affect bone marrow function.

Trial ID:
2024-516212-24-00
Protocol code:
FASCINATION
NCT ID:
NCT03906292
Trial Phase:
Therapeutic exploratory (Phase II)

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