Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study Comparing BGB-16673 to Drug Combinations for Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Treated with BTK and BCL2 Inhibitors

Fast replyRegistered drug
Clinical Trials Concierge

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

Featured sites

Sites that work closely with us on this trial

What is this trial about?

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

This clinical trial is focused on studying treatments for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). These are types of cancer that affect the blood and lymph nodes. The study will compare a new medication called BGB-16673 with other treatment options chosen by doctors. These options include combinations of medications such as Idelalisib plus Rituximab, Bendamustine plus Rituximab, or Venetoclax plus Rituximab. The purpose of the study is to see how well these treatments work in patients who have already been treated with other specific cancer medications.

Participants in the study will be randomly assigned to receive either the new medication BGB-16673 or one of the other treatment options. The study will monitor the participants over a period to see how long they live without the disease getting worse. This is known as progression-free survival. The study will also look at other factors, such as overall survival, which is the time from the start of the study until death from any cause, and the response of the disease to the treatment. The study will also track any side effects that occur during the treatment.

The study aims to provide more information about the effectiveness of BGB-16673 compared to the other treatment options. It will help determine which treatment might be better for patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma who have previously been treated with certain other cancer medications. The study is expected to continue until 2030, with recruitment starting in 2025.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization. It ensures that each participant has an equal chance of receiving any of the treatments being tested.

  2. Step 2

    Treatment assignment

    If assigned to Arm A, you will receive the medication BGB-16673 in the form of a film-coated tablet taken orally. The dosage and frequency will be determined by the study team.

    If assigned to Arm B, you will receive a combination of medications. The options include idelalisib plus rituximab, bendamustine plus rituximab, or venetoclax plus rituximab. The specific combination will be chosen by the study investigator based on your medical history and condition.

  3. Step 3

    Medication administration

    For oral medications such as BGB-16673, idelalisib, and venetoclax, you will take the tablets by mouth as directed by the study team.

    For infusion medications such as rituximab and bendamustine, you will receive these through a vein (intravenous infusion) at a healthcare facility. The frequency and duration of these infusions will be specified by the study team.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular visits will be scheduled to monitor your health and the effects of the treatment. This includes physical exams, blood tests, and other assessments as needed.

    You will be asked to report any side effects or changes in your condition to the study team promptly.

  5. Step 5

    End of treatment

    At the end of the treatment period, a final evaluation will be conducted to assess your response to the treatment and overall health.

    You may be asked to continue follow-up visits for a specified period to monitor long-term effects and gather additional data.

Who can join the trial?

16 criteria

  • Patients must sign a form to show they understand the study and agree to participate.
  • Patients must be at least 18 years old or the legal age of consent in their area.
  • Patients must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that requires treatment.
  • Patients must have previously received treatment for CLL/SLL with both a BTKi (Bruton's Tyrosine Kinase inhibitor) and a BCL2i (B-cell lymphoma 2 inhibitor).
  • For patients to be considered for the bendamustine + rituximab treatment option, their disease should not have a del(17p) or TP53 mutation.
  • For patients to be considered for the venetoclax + rituximab treatment option, their last response to a BCL2i-based treatment should have been a Partial Response (PR) or better, and they should have tolerated previous BCL2i treatment.
  • Patients with SLL must have measurable disease, meaning at least one lymph node is larger than 1.5 cm in size.
  • Patients must have an ECOG Performance Status of 0 to 2, which is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.
  • Patients must have adequate organ function, which includes:
    • Adequate bone marrow function, with specific levels of white blood cells, platelets, and hemoglobin.
    • Adequate kidney function, with a certain level of glomerular filtration rate (GFR).
    • Normal levels of bilirubin, amylase, and lipase in the blood.
    • Adequate liver function, with specific levels of liver enzymes AST and ALT.
    • Normal blood clotting function.
    • Female patients of childbearing potential must use a highly effective method of birth control and refrain from donating eggs during the study and for a specified time after the last dose of study medication.
    • Nonsterile male patients must use a highly effective method of birth control and refrain from donating sperm during the study and for a specified time after the last dose of study medication.
    • For patients to be considered for the idelalisib + rituximab treatment option, their disease must be CLL, not SLL.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer than Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or comply with the study requirements.
  • Patients who have any other medical condition that might interfere with the study results or pose a risk to the patient.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a known allergy or adverse reaction to the study drugs or similar medications.
  • Patients who have a history of substance abuse or any condition that might affect their ability to participate in the study.
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

  • BGB-16673

    is a new medication being tested in this study. It is designed to help treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. These are types of blood cancers. The goal of this medication is to stop or slow down the growth of cancer cells, which may help patients live longer without their disease getting worse.

  • Idelalisib

    is a medication used in combination with another drug called rituximab. It works by blocking certain signals in cancer cells that help them survive and grow. By doing this, idelalisib can help reduce the number of cancer cells in the body and slow down the progression of the disease.

  • Rituximab

    is a medication that is often used in combination with other drugs to treat certain types of blood cancers. It works by targeting and attaching to specific proteins on the surface of cancer cells, which helps the body's immune system to destroy these cells. This can help reduce the number of cancer cells and slow down the progression of the disease.

  • Bendamustine

    is a chemotherapy drug that is used in combination with rituximab. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. This can help reduce the number of cancer cells in the body and slow down the progression of the disease.

  • Venetoclax

    is a medication used in combination with rituximab for treating certain types of blood cancers. It works by blocking a protein that helps cancer cells survive. By doing this, venetoclax can help kill cancer cells and reduce their number in the body, which may slow down the progression of the disease.

What is already known about the treatment

BGB-16673 – BGB-16673 is a medication currently being studied in clinical trials for its effectiveness in treating chronic lymphocytic leukemia and small lymphocytic lymphoma. It is administered orally, meaning it is taken by mouth in the form of a pill. The main goal of the study is to see how well BGB-16673 works compared to other treatments chosen by doctors, such as combinations of idelalisib, bendamustine, venetoclax, and rituximab. BGB-16673 works by targeting specific proteins in cancer cells, which helps to stop their growth and spread. It is classified as a targeted therapy, which means it aims to attack cancer cells more precisely than traditional chemotherapy.

Investigated diseases

  • Chronic Lymphocytic Leukemia

    Chronic Lymphocytic Leukemia (CLL) is a type of cancer that affects the blood and bone marrow. It typically progresses slowly and is characterized by the accumulation of abnormal lymphocytes, a type of white blood cell. These abnormal cells can crowd out healthy blood cells, leading to symptoms such as fatigue, swollen lymph nodes, and frequent infections. Over time, CLL can cause the spleen and liver to enlarge. The disease may remain stable for years, but in some cases, it can progress to a more aggressive form. As CLL advances, it can interfere with the production of other blood cells, leading to anemia and increased bleeding.

  • Small Lymphocytic Lymphoma

    Small Lymphocytic Lymphoma (SLL) is a type of non-Hodgkin lymphoma that primarily affects the lymph nodes. It is closely related to Chronic Lymphocytic Leukemia, with both diseases involving the same type of cancerous lymphocytes. SLL progresses slowly and is characterized by the enlargement of lymph nodes, which may be painless. As the disease advances, it can spread to other lymphoid tissues and organs, such as the spleen and liver. Patients may experience symptoms like night sweats, weight loss, and fatigue. The disease can remain indolent for a long time but may eventually transform into a more aggressive form.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518893-15-00Protocol codeBGB-16673-302Estimated enrolment253 patientsSponsorBeOne Medicines AG

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.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).