Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Lisaftoclax and Acalabrutinib for Patients with Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of a new treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). The study involves two medications: Lisaftoclax, also known by its code name APG-2575, and Acalabrutinib, marketed as Calquence. Lisaftoclax is a small molecule that targets a protein called Bcl-2, which helps cancer cells survive. Acalabrutinib is a targeted treatment that inhibits a specific enzyme known as Bruton’s tyrosine kinase, which plays a role in the growth of cancer cells.

The purpose of the study is to compare the combination of Lisaftoclax and Acalabrutinib with Acalabrutinib alone in patients who have previously been treated for CLL or SLL. Participants will receive either the combination treatment or Acalabrutinib alone. The study will monitor the progression of the disease and assess the safety and effectiveness of the treatments over a period of time. The trial will also include a placebo group to help understand the effects of the treatments better.

Participants will take the medications orally, in the form of tablets or capsules, for a maximum period of 76 weeks. Throughout the study, regular check-ups and assessments will be conducted to monitor the participants' health and the progression of their disease. The study aims to provide valuable information on whether the combination of Lisaftoclax and Acalabrutinib offers better outcomes for patients with CLL or SLL compared to Acalabrutinib alone.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, previous treatment history, and health status.

    Written informed consent is required to participate in the study.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving lisaftoclax in combination with acalabrutinib, and the other receiving acalabrutinib alone.

    This process ensures that the study results are unbiased.

  3. Step 3

    Treatment administration

    Participants in the combination group take lisaftoclax tablets and acalabrutinib capsules or tablets orally.

    Participants in the monotherapy group take acalabrutinib capsules or tablets orally.

    The dosage and frequency of administration are determined by the study protocol and are monitored by the study team.

  4. Step 4

    Monitoring and assessments

    Regular assessments are conducted to monitor health status, including blood tests and imaging studies.

    The study team evaluates the progression of the disease and any side effects experienced.

  5. Step 5

    Completion of treatment

    The treatment phase continues until disease progression, unacceptable side effects, or completion of the study period.

    Participants are monitored for a period after treatment to assess long-term effects and outcomes.

  6. Step 6

    Follow-up

    After completing the treatment phase, follow-up visits are scheduled to monitor overall health and any long-term effects of the treatment.

    These visits may include additional tests and assessments as required by the study protocol.

Who can join the trial?

8 criteria

  • Must be **18 years or older**.
  • Must have **Chronic Lymphocytic Leukemia (CLL)** or **Small Lymphocytic Lymphoma (SLL)** and meet specific treatment guidelines.
  • Must have been treated with **acalabrutinib** alone for at least **12 months** and have a stable disease or partial response with certain risk factors.
  • Must have an **ECOG performance status** of 0 to 2, which is a scale used to assess how a disease affects a patient's daily living abilities.
  • Must have **adequate bone marrow function**, meaning the bone marrow is working well enough to produce blood cells without help from medications or transfusions.
  • Must have **adequate kidney function**, which means the kidneys are working well enough to filter waste from the blood.
  • Must have **adequate liver function**, meaning the liver is working well enough to process substances in the body.
  • Must be able and willing to **provide written consent** and follow the study's schedule and requirements.

Who cannot join the trial?

4 criteria

  • Patients who have not been previously treated with acalabrutinib cannot participate.
  • Patients with medical conditions other than **Chronic Lymphocytic Leukemia** or **Small Lymphocytic Lymphoma** are excluded.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are excluded.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Lisaftoclax (APG-2575)

    is a medication being studied for its potential to help treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. It is being tested to see if it can improve the time patients live without their disease getting worse when used in combination with another medication.

  • Acalabrutinib

    is a medication that is already used to treat certain types of blood cancers, including chronic lymphocytic leukemia and small lymphocytic lymphoma. In this study, it is being used both alone and in combination with lisaftoclax to see if the combination can provide better outcomes for patients who have been previously treated with acalabrutinib.

What is already known about the treatment

Lisaftoclax – Lisaftoclax is administered orally and is currently being studied in clinical trials for its effectiveness in treating Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). It is in the investigational stage, with ongoing research to determine its benefits and safety. The main therapeutic indication for lisaftoclax is for patients who have previously been treated for CLL/SLL. At the molecular level, lisaftoclax works by inhibiting a protein that helps cancer cells survive, thereby promoting cancer cell death. It is classified as a BCL-2 inhibitor, a type of targeted therapy aimed at specific proteins involved in cancer cell survival.

Investigated diseases

  • Chronic Lymphocytic Leukemia

    This is a type of cancer that affects the blood and bone marrow, characterized by the production of too many abnormal lymphocytes, a type of white blood cell. It progresses slowly and may not cause symptoms for years. Over time, the abnormal cells can crowd out healthy blood cells, leading to issues like anemia, infections, and bleeding problems. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The progression can vary greatly among individuals, with some experiencing rapid changes and others remaining stable for long periods.

  • Small Lymphocytic Lymphoma

    This is a type of non-Hodgkin lymphoma that primarily affects the lymph nodes, but it is closely related to chronic lymphocytic leukemia. It involves the slow accumulation of small, mature lymphocytes in the lymph nodes, which can lead to swelling and discomfort. The disease progresses slowly, often without symptoms in the early stages. As it advances, it can cause symptoms such as fatigue, night sweats, and weight loss. The abnormal lymphocytes can also spread to other organs, including the liver and spleen. The progression rate can vary, with some individuals experiencing a stable condition for years.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508005-24-00Protocol codeAPG2575CG301Estimated enrolment489 patientsSponsorAscentage Pharma Group Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.