Study of Lisaftoclax and Acalabrutinib for Patients with Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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What is this study about?

This clinical trial is focused on studying a new treatment for patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), which are types of blood cancers. The study will test a new drug called Lisaftoclax (also known by its code name APG-2575) in combination with another medication called Acalabrutinib. These drugs will be compared to a standard treatment known as immunochemotherapy, which involves using medicines that help the immune system fight cancer.

The purpose of the study is to see how well the combination of Lisaftoclax and Acalabrutinib works in treating patients with newly diagnosed CLL or SLL. Participants in the study will be randomly assigned to receive either the new drug combination or the standard immunochemotherapy. The study will monitor the participants over a period of time to see how their disease progresses and to check for any side effects from the treatments.

Throughout the study, participants will receive regular check-ups and tests to track their health and the effectiveness of the treatment. The study aims to provide valuable information on whether the new drug combination can offer a better treatment option for patients with CLL or SLL. The study is expected to continue for several years to gather comprehensive data on the outcomes of the treatments being tested.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

Blood tests and imaging may be performed to establish a baseline for the study.

2 randomization

Participants are randomly assigned to one of two groups: one receiving lisaftoclax with acalabrutinib, and the other receiving standard immunochemotherapy.

3 treatment phase

For those in the lisaftoclax and acalabrutinib group, lisaftoclax is taken orally in tablet form. The dosage and frequency are determined by the study protocol.

Acalabrutinib is also taken orally in tablet form, with specific dosage and frequency as per the study guidelines.

Participants in the immunochemotherapy group receive a combination of medications, including cyclophosphamide monohydrate, rituximab, fludarabine phosphate, and chlorambucil. These are administered either orally or through intravenous infusion, depending on the specific medication.

4 monitoring and follow-up

Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects. This includes blood tests, imaging, and other necessary evaluations.

Follow-up visits are scheduled at intervals specified by the study protocol to ensure ongoing assessment of health and response to treatment.

5 completion of treatment

Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the treatment.

Participants may be asked to return for additional follow-up visits to monitor long-term outcomes and any delayed side effects.

Who Can Join the Study?

Must be at least 18 years old.
Must be able to understand and willingly sign a written consent form approved by the Ethics Committee before any study-related procedures.
Must be willing and able to complete study procedures and follow-up exams.
Must have been diagnosed with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) based on specific guidelines and need treatment.
Must have a measurable disease, which means having a certain number of cancer cells in the blood, or enlarged lymph nodes, liver, or spleen due to CLL.
Must have an ECOG Performance Status score between 0 and 2, which measures daily living abilities.
Must have a QT interval (a heart rhythm measurement) within a certain range on an ECG (a heart test).
Must have adequate bone marrow function without recent use of growth factors or blood transfusions. This includes having enough white blood cells, platelets, and hemoglobin.
Must have adequate liver, kidney, and blood clotting functions, with specific limits on liver enzymes, bilirubin, creatinine, and blood clotting times.
Men and women who can have children must use effective birth control during the study and for at least 3 months after the last dose of the study drug. Men must not donate sperm during this time.
Women who can have children must have a negative pregnancy test within 14 days before the first dose of the study drug. If the test is more than 7 days old, a urine test must be negative before the first dose.

Who Cannot Join the Study?

Patients who have not been newly diagnosed with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma cannot participate. These are types of blood cancers.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are not detailed here but are important for ensuring the safety and effectiveness of the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Umbal – Prof. D-R Stoyan Kirkovich AD	Stara Zagora	Bulgaria
University Hospital Ostrava	Ostrava	Czechia
Specialized Hospital For Active Treatment Of Hematological Diseases EAD	Sofia	Bulgaria
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Pcac Tobbw Hvpcwhgu Ubzfyzrdpfgg	Sabadell	Spain
Ihksahwa Cssreg Davdfdzgwlscrdhht	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Bulgaria	Not yet recruiting	10.12.2024
Czechia	Recruiting	10.12.2024
Spain	Recruiting	10.12.2024

Trial locations

Investigated drugs:

Lisaftoclax (APG-2575) is a medication being studied for its potential to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is being tested in combination with another drug to see if it can help stop the cancer from progressing.

Acalabrutinib is a medication used in the treatment of certain types of blood cancers, including chronic lymphocytic leukemia (CLL). In this study, it is combined with Lisaftoclax to evaluate if the combination is more effective than traditional treatments.

Immunochemotherapy is a standard treatment approach for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It combines chemotherapy, which uses drugs to kill cancer cells, with immunotherapy, which helps the immune system fight cancer. This study compares the effectiveness of the new drug combination against this traditional treatment method.

Chronic Lymphocytic Leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the production of too many abnormal white blood cells. These cells accumulate over time, crowding out healthy blood cells and impairing the immune system. The disease often progresses slowly, and many people may not experience symptoms for years. As it advances, it can lead to swollen lymph nodes, fatigue, and an increased risk of infections. The abnormal cells can also spread to other parts of the body, such as the liver and spleen.

Small Lymphocytic Lymphoma – This is a type of non-Hodgkin lymphoma that primarily affects the lymph nodes. It is closely related to chronic lymphocytic leukemia, with the main difference being the location of the cancer cells. In small lymphocytic lymphoma, the cancerous cells are mainly found in the lymph nodes rather than the blood and bone marrow. The disease typically progresses slowly, and symptoms may include swollen lymph nodes, fatigue, and night sweats. Over time, it can affect other organs and tissues, leading to further complications.

Trial ID:

2024-514084-26-00

Protocol code:

APG2575CC301

NCT ID:

NCT06319456

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Lisaftoclax and Acalabrutinib for Patients with Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?