Study on Asciminib and Asciminib Hydrochloride for Patients with Chronic Myelogenous Leukemia in Chronic Phase After Two or More Tyrosine Kinase Inhibitors

3 1 1 1

What is this study about?

This clinical trial is focused on studying a type of blood cancer called Chronic Myelogenous Leukemia in chronic phase (CML-CP). The study is testing a treatment using a medication called Asciminib, which is taken as a film-coated tablet. Another form of the medication, known as Asciminib Hydrochloride, is also being used. Both forms of the medication are taken orally, meaning they are swallowed like a pill.

The purpose of the study is to see how well patients with CML-CP respond to Asciminib after they have already been treated with at least two other medications called tyrosine kinase inhibitors (TKIs). These TKIs include drugs like imatinib, nilotinib, dasatinib, bosutinib, radotinib, or ponatinib. The study will look at how many patients achieve a specific type of response called a molecular response at different times, such as at 48 weeks. The study will also monitor the safety of the treatment by checking for any side effects and changes in health markers.

Participants in the study will take the medication for a period of up to 144 weeks. During this time, they will have regular check-ups to monitor their health and the effectiveness of the treatment. The study aims to provide more information on how well Asciminib works for patients with CML-CP who have not had success with other treatments.

1 joining the study

Participation begins after signing an informed consent form. This confirms understanding of the study and agreement to participate.

Eligibility includes being 18 years or older with a diagnosis of Chronic Myelogenous Leukemia in chronic phase (CML-CP) and previous treatment with at least two tyrosine kinase inhibitors (TKIs).

2 treatment initiation

The treatment involves taking asciminib orally. The specific dosage and frequency will be provided by the healthcare team.

The goal is to optimize treatment for those who have not achieved a molecular response with previous TKI therapies.

3 monitoring and assessments

Regular monitoring will occur to assess the response to treatment. This includes checking for molecular response rates at various intervals: weeks 12, 24, 36, 48, 72, 96, and 144.

Safety assessments will be conducted to monitor for any adverse effects, changes in laboratory values, and other health indicators.

4 end of treatment evaluation

The primary endpoint is to achieve a molecular response at 48 weeks.

Secondary endpoints include evaluating the type and frequency of adverse events, and other health outcomes over the course of the study.

5 completion of study

The study is estimated to conclude by January 20, 2025.

Final assessments will be conducted to evaluate the overall effectiveness and safety of the treatment.

Who Can Join the Study?

  • The patient must provide a signed informed consent before joining the study. This means they agree to participate after understanding the details of the study.
  • The patient must be a male or female who is at least 18 years old and has been diagnosed with Chronic Myelogenous Leukemia in chronic phase (CML-CP).
  • The patient must have been treated with at least two or more previous TKIs. TKIs are a type of medication used to treat certain types of cancer, including imatinib, nilotinib, dasatinib, bosutinib, radotinib, or ponatinib.
  • The patient must have experienced a warning or failure of the most recent TKI therapy, or they must not be able to tolerate it. This is based on guidelines from the 2020 ELN Recommendations.
  • The patient must have an ECOG performance status of 0, 1, or 2. This is a scale used to assess how a patient’s disease is affecting their daily living abilities, with 0 being fully active and 2 indicating some limitations but still able to care for themselves.
  • The patient must have adequate end organ function, which will be determined by specific laboratory tests.

Who Cannot Join the Study?

  • Patients who have not been diagnosed with Chronic Myelogenous Leukemia in chronic phase (CML-CP). This is a type of blood cancer that affects the bone marrow and blood.
  • Patients who have not received at least two previous treatments with TKI medications. TKI stands for Tyrosine Kinase Inhibitors, which are drugs used to treat certain types of cancer.
  • Patients who already show a molecular response at the start of the study. A molecular response means that the cancer cells in the blood are reduced to a very low level.
  • Patients who are not within the specified age range for the study.
  • Patients who are not willing or able to follow the study procedures.
  • Patients who are part of a vulnerable population that the study is not designed to include.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Jena KöR Jena Germany
Medical University Of Graz Graz Austria

Other Sites

Site Name City Country Status
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Hospital Universitario 12 De Octubre Madrid Spain
Instytut Hematologii I Transfuzjologii Warsaw Poland
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Hospital Universitario Basurto Bilbao Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Staedtisches Krankenhaus Kiel GmbH Kiel Germany
Pratia Hematologia Sp. z o.o. Katowice Poland
Universita’ Degli Studi Di Verona Verona Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse Vienna Austria
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universidade De Santiago De Compostela Santiago De Compostela Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Beaujon Clichy France
Csuetm Lhkd Bumxyr Lyon France
Ozcbecykidcmvo Lgpz Giby Linz Austria
Loozu Glagxqo Hxjsiaek Ov Atoytq Athens Greece
Gygklv Ueciemrrrd Fawodoblr Frankfurt Germany
Upwmgivosk Dylfl Ssisw Df Rhff Le Sewxtyqd Rome Italy
Hpdturot Vxgi dwbqjear Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.10.2021
France France
Not recruiting
01.10.2021
Germany Germany
Not recruiting
01.10.2021
Greece Greece
Not recruiting
01.10.2021
Italy Italy
Not recruiting
01.10.2021
Poland Poland
Not recruiting
01.10.2021
Spain Spain
Not recruiting
01.10.2021

Trial locations

Asciminib is a medication being studied for its effectiveness in treating patients with Chronic Myelogenous Leukemia in the chronic phase. It is used in patients who have already been treated with two or more tyrosine kinase inhibitors but have not achieved a molecular response. Asciminib works by targeting specific proteins in cancer cells, which may help to stop their growth and spread.

Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of white blood cells. In the chronic phase, the disease progresses slowly and may not cause noticeable symptoms initially. Over time, the accumulation of abnormal cells can lead to fatigue, weight loss, and an increased risk of infections. The chronic phase is typically the earliest stage of the disease, where the body still functions relatively normally. If untreated, CML-CP can progress to more aggressive phases. The disease is often associated with a specific genetic abnormality known as the Philadelphia chromosome.

Trial ID:
2024-511381-36-00
Protocol code:
CABL001A2302
Trial Phase:
Therapeutic confirmatory (Phase III)

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