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

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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). 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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Universitaet Leipzig	Leipzig	Germany
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Azienda Ospedaliera Di Perugia	Perugia	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Institut Fuer Versorgungsforschung In Der Onkologie GbR	Koblenz	Germany
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza	Brzozow	Poland
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Pratia S.A.	Skorzewo	Poland
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie	Homburg	Germany
University Hospital Ostrava	Ostrava	Czechia
Ueggofsevj Mjpgeun Cmvwhp Hijmsnkzxetydhzvo	Hamburg	Germany
Uiebuxzflhumgilmkorbw Emgdi Aar	Essen	Germany
Urulamkauwtaksregozvf Ahvlepvr	Augsburg	Germany
Wmlthjmiyup Wkgvcwjyxkjgxgzseiyb Ckgcpbx Odchjnpvm I Tkhtzgykfcfqz Ia Mlwbvgexung W Ldzpi	Lodz	Poland
Cacegkr fyz Hyfnqryvffg uvh Ofuxhzury ai Byyqxgjzvnkmqogdtzobq	Frankfurt	Germany
Awpjphxvu Uha	Amsterdam	The Netherlands
Ubocecujjrbrnbyhnpdwe Mcnhardp Apm	Munster	Germany
Pnglsh at Vtihkrhuq	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	01.07.2025
Germany	Recruiting	01.07.2025
Italy	Recruiting	01.07.2025
Poland	Recruiting	01.07.2025
The Netherlands	Recruiting	01.07.2025

Trial locations

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.

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 ID:

2024-518893-15-00

Protocol code:

BGB-16673-302

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?