Study of Lisaftoclax Alone or with Drug Combination for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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What is this study about?

This clinical trial is focused on studying treatments for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), which are types of blood cancers. The study is investigating a new medication called Lisaftoclax (also known as APG-2575), which is being tested alone and in combination with other treatments. These additional treatments include Rituximab, Acalabrutinib, Ibrutinib, and Zanubrutinib. The purpose of the study is to evaluate the safety and effectiveness of these treatments in patients whose disease has returned or is resistant to previous treatments.

Participants in the study will receive the medication Lisaftoclax either by itself or together with one of the other mentioned drugs. The study will monitor how well patients tolerate the treatments and will look for any side effects. The goal is to find the best dose of Lisaftoclax that can be safely given to patients. The study will also assess how effective the treatments are in controlling the disease.

Throughout the study, patients will be closely monitored by healthcare professionals. The study will involve regular check-ups and tests to track the progress of the disease and the patient’s response to the treatment. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments. The study aims to provide valuable information that could lead to better treatment options for people with CLL and SLL.

1 Joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The patient must provide written consent to participate.

The patient will undergo initial assessments to confirm eligibility, including medical history review and physical examination.

2 Initial treatment phase

The patient will begin treatment with APG-2575, which is taken orally. The dosage and frequency will be determined based on the patient’s specific needs and the study protocol.

The patient may receive APG-2575 alone or in combination with other medications such as rituximab (administered via intravenous infusion), acalabrutinib, ibrutinib, or zanubrutinib (all taken orally).

3 Monitoring and assessments

Throughout the trial, the patient will undergo regular monitoring to assess the safety and effectiveness of the treatment. This includes blood tests, imaging studies, and other necessary evaluations.

The patient will be monitored for any side effects or adverse reactions to the medications.

4 Dose adjustments

Based on the patient’s response to the treatment and any side effects experienced, the dosage of APG-2575 or other medications may be adjusted.

The goal is to find the maximum tolerated dose that provides the best therapeutic effect with manageable side effects.

5 Continuation of treatment

The patient will continue the treatment regimen as long as it is deemed beneficial and safe.

Regular follow-up visits will be scheduled to monitor the patient’s progress and make any necessary adjustments to the treatment plan.

6 End of study participation

The patient’s participation in the study will conclude at the end of the trial period or if the treatment is no longer effective or safe.

A final assessment will be conducted to evaluate the overall outcomes of the treatment.

Who Can Join the Study?

Must be at least 18 years old.
Must be able to understand and willing to sign a written consent form before any study procedures begin.
Must be willing and able to follow study procedures and attend follow-up exams.
Must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), which are types of blood cancers. The patient must have had a return of the disease or not responded to at least one previous treatment and need treatment according to specific criteria.
Must have an ECOG score of 2 or less, which is a measure of daily living abilities where lower scores indicate better function.
Must show clear signs of disease progression, such as increasing white blood cell count, larger lymph nodes or spleen, worsening blood cell counts, or symptoms like night sweats, fatigue, significant weight loss, or fever without infection.
Must have adequate bone marrow function, meaning certain blood cell counts must be at specific levels without recent transfusions.
Must have proper kidney and liver function, as shown by specific blood test results.
Females who can have children must have a negative pregnancy test before starting the study drug and on the first day of taking the study drug if more than 7 days have passed since the initial test.
Females who can have children and males who are not sterile must use at least one reliable method of birth control during the study and for 90 days after stopping the study drug. Options include total abstinence, having a sterile partner, using an intrauterine device (IUD), using a double-barrier method, or using hormonal contraceptives for at least 3 months before starting the study drug.
Male patients must not donate sperm from the start of the study drug until 90 days after the last dose.

Who Cannot Join the Study?

Patients who have other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had another type of cancer within the last 2 years, except for certain skin cancers or other specific cases.
Patients who have had a major surgery within the last 4 weeks.
Patients who have an active infection that requires treatment.
Patients who have a known allergy to any of the study medications.
Patients who have received another investigational drug within the last 4 weeks.
Patients who have a history of certain heart conditions.
Patients who have uncontrolled high blood pressure.
Patients who have a history of drug or alcohol abuse within the last 2 years.
Patients who have a known history of HIV, hepatitis B, or hepatitis C.
Patients who have any condition that, in the opinion of the study doctor, makes them unsuitable for 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
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej	Biala Podlaska	Poland
University Of Debrecen	Debrecen	Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz	Nyiregyhaza	Hungary

Trial status

Country	Status	Recruitment Start
Hungary	Recruiting	03.01.2022
Poland	Recruiting	03.01.2022

Trial locations

Investigated drugs:

APG-2575 is an experimental medication being studied for its potential to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not responded to previous treatments or whose disease has returned. It is taken by mouth and is being tested both on its own and in combination with other medications to determine its safety, how well it is tolerated, and its effectiveness in treating these conditions.

Rituximab is a medication that is used to treat certain types of cancer, including CLL and SLL. It works by targeting specific cells in the immune system and is often used in combination with other cancer treatments to improve their effectiveness.

Acalabrutinib is a medication used to treat certain types of blood cancers, including CLL and SLL. It works by blocking a specific protein that helps cancer cells grow and survive. In this study, it is being used in combination with APG-2575 to see if the combination is more effective than using either medication alone.

Ibrutinib is a medication that is used to treat various types of blood cancers, including CLL and SLL. It works by interfering with the growth and spread of cancer cells. In this trial, it is being combined with APG-2575 to evaluate the effectiveness of the combination in treating these conditions.

Zanubrutinib is another medication used to treat certain blood cancers, including CLL and SLL. It functions similarly to ibrutinib by targeting specific proteins involved in cancer cell growth. The study is testing its use in combination with APG-2575 to determine if this combination can provide better outcomes for patients.

Chronic Lymphocytic Leukemia (CLL) – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of abnormal white blood cells called lymphocytes. These abnormal cells accumulate over time, crowding out healthy blood cells and impairing the immune system. CLL progresses slowly in most cases, and many individuals may not experience symptoms for years. As the disease advances, it can lead to symptoms such as fatigue, swollen lymph nodes, and frequent infections. The progression of CLL can vary greatly among individuals, with some experiencing a more aggressive form of the disease.

Small Lymphocytic Lymphoma (SLL) – This is a type of non-Hodgkin lymphoma that is closely related to CLL, involving the same type of cancerous lymphocytes. Unlike CLL, which primarily affects the blood and bone marrow, SLL mainly involves the lymph nodes. The disease progresses slowly, often without causing symptoms for a long time. As it advances, it can lead to swollen lymph nodes, fatigue, and an increased risk of infections. SLL and CLL are considered different manifestations of the same disease, with SLL being more localized to the lymphatic system.

Trial ID:

2024-515654-25-00

Protocol code:

APG-2575CU101

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Lisaftoclax Alone or with Drug Combination for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?