Study on the Effectiveness of Asciminib and Imatinib for Patients with Chronic Myelogenous Leukemia Not Responding to Imatinib

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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 involves patients who have been previously treated with a medication called imatinib but have not achieved a deep molecular response, which means the cancer cells are still present at a certain level. The trial will test the effectiveness of adding a new medication called asciminib to imatinib, compared to continuing with imatinib alone or switching to another medication called nilotinib.

The purpose of the study is to determine if the combination of asciminib and imatinib is more effective than the other treatment options. Participants will be randomly assigned to one of the treatment groups and will take the medications orally, which means by mouth, in the form of film-coated tablets or capsules. The study will last for a period of up to 96 weeks, during which the participants’ response to the treatment will be monitored.

Throughout the study, the main focus will be on the rate of achieving a deep molecular response, known as MR4.5, at 48 weeks. This response indicates a very low level of cancer cells in the blood. The study will also look at the safety of the treatments, any side effects, and how the medications are processed in the body. Participants will have regular check-ups and tests to monitor their health and the effectiveness of the treatment.

1 joining the study

Upon joining the study, the patient must have a confirmed diagnosis of chronic myelogenous leukemia in the chronic phase (CML-CP) and have been previously treated with imatinib for at least one year.

The patient must not have achieved a deep molecular response during prior imatinib treatment.

2 randomization

The patient will be randomly assigned to one of the following treatment groups: continued imatinib, imatinib plus asciminib, or switch to nilotinib.

This randomization determines the specific treatment plan the patient will follow during the study.

3 treatment administration

If assigned to the imatinib group, the patient will continue taking imatinib 400 mg once daily.

If assigned to the imatinib plus asciminib group, the patient will take imatinib 400 mg once daily along with asciminib 40 mg or 60 mg once daily.

If assigned to the nilotinib group, the patient will switch to nilotinib, taken as prescribed.

4 monitoring and assessments

Throughout the study, the patient’s response to treatment will be monitored through regular assessments.

The primary goal is to evaluate the molecular response rate at 48 weeks, specifically the MR4.5 rate, which indicates a deep level of response.

5 completion of study

The study is expected to conclude by April 2025.

Upon completion, the patient’s overall response and any side effects experienced during the study will be evaluated.

Who Can Join the Study?

You must sign a form agreeing to participate in the study.
You need to be a man or woman who is at least 18 years old and has been diagnosed with Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
You should have been treated with a medication called imatinib for at least one year, taking at least 300 mg daily.
Your BCR-ABL1 levels should be more than 0.01% and less than or equal to 1% at the start of the study. This will be checked with a special test. You should not have reached a deep response to the treatment before.
Your blood tests must show the following values before you can join the study:
- Absolute Neutrophil Count (a type of white blood cell) should be at least 1.5 x 10⁹ L.
- Platelets (cells that help with blood clotting) should be at least 75 x 10⁹/L.
- Hemoglobin (a protein in red blood cells) should be at least 9 g/dL.
- Serum creatinine (a measure of kidney function) should be less than 1.5 mg/dL.
- Total bilirubin (a substance made by the liver) should be less than or equal to 1.5 times the normal limit, unless you have a condition called Gilbert’s syndrome, in which case it can be up to 3 times the normal limit.
- Aspartate aminotransaminase (AST) and Alanine aminotransaminase (ALT) (liver enzymes) should be less than or equal to 3 times the normal limit.
- Alkaline phosphatase (ALP) should be less than or equal to 2.5 times the normal limit.
- Serum lipase (an enzyme related to the pancreas) should be less than or equal to 1.5 times the normal limit. If it is higher than normal but less than or equal to 1.5 times the normal limit, it should not be a concern for pancreatitis.
Your blood levels of potassium, calcium, and magnesium should be normal or can be corrected with supplements before joining the study. If these levels are slightly higher, it is acceptable if your kidney function is normal.

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 been previously treated with imatinib. Imatinib is a medication used to treat certain types of cancer.
Patients who have already achieved a deep molecular response. This means the cancer cells in the blood are very low or undetectable.
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 have other medical conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fakultni Nemocnice Brno	Brno	Czechia
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse	Vienna	Austria
Irhhncnf Cxetjy Djjwfduoxaqyzyyzp	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.12.2020
Czechia	Not recruiting	01.12.2020
France	Not recruiting	01.12.2020
Italy	Not recruiting	01.12.2020
Spain	Not recruiting	01.12.2020

Trial locations

Investigated drugs:

Asciminib is a medication being studied for its effectiveness in treating patients with chronic myeloid leukemia (CML) who have not achieved a deep molecular response with previous treatments. It is taken orally and is being tested in combination with another medication to see if it can improve treatment outcomes.

Imatinib is a medication that is commonly used to treat chronic myeloid leukemia (CML). In this study, it is being used both as a standalone treatment and in combination with asciminib to compare the effectiveness of different treatment strategies for patients who have not achieved a deep molecular response.

Nilotinib is another medication used to treat chronic myeloid leukemia (CML). In this trial, it is being used as an alternative treatment option for patients who have not achieved a deep molecular response with imatinib. The study aims to determine if switching to nilotinib can provide better outcomes for these patients.

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, it can lead to fatigue, weight loss, and an increased risk of infections due to the abnormal proliferation of white blood cells. The disease is associated with a specific genetic abnormality known as the Philadelphia chromosome. Patients in this phase may have been previously treated with medications like imatinib but have not achieved a deep molecular response. The focus is often on monitoring the molecular response to treatment to manage the disease effectively.

Trial ID:

2024-515040-23-00

Protocol code:

CABL001E2201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Asciminib and Imatinib for Patients with Chronic Myelogenous Leukemia Not Responding to Imatinib

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?