Study of sonrotoclax plus obinutuzumab or rituximab compared to venetoclax plus rituximab in patients with relapsed or refractory chronic lymphocytic leukemia

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What is this study about?

This clinical trial studies treatments for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma in patients whose disease has returned or did not respond to previous treatments. The study compares two treatment combinations: sonrotoclax plus either obinutuzumab or rituximab versus venetoclax plus rituximab. These medications work by targeting and destroying cancer cells in different ways.

The study aims to determine which treatment combination is more effective at preventing the disease from getting worse. Patients will receive either tablets of sonrotoclax or venetoclax to take by mouth, along with infusions of obinutuzumab or rituximab given through a vein. The medications will be given over several months according to a specific schedule.

Throughout the study, doctors will monitor how well the treatments work by performing various tests and examining patients regularly. They will check for the presence of cancer cells in the blood, measure how long patients live without their disease getting worse, and track any side effects that may occur. The study is expected to continue until the end of 2031.

1 Initial treatment phase

You will receive treatment with either sonrotoclax plus obinutuzumab, sonrotoclax plus rituximab, or venetoclax plus rituximab

Venetoclax is taken as tablets by mouth in different strengths (10 mg, 50 mg, and 100 mg)

Rituximab and obinutuzumab are given through an intravenous infusion (directly into your vein)

2 Treatment monitoring

Your blood will be tested regularly to check for minimal residual disease (very small amounts of cancer cells)

Blood samples will be taken at specific points during treatment: at cycle 8 day 1, cycle 11 day 1, and cycle 14 day 1

Regular assessments will monitor how your body responds to the treatment

Your doctor will check for any side effects and perform physical examinations

3 Response evaluation

Your response to treatment will be evaluated regularly

Doctors will look for signs if the cancer is getting better, staying the same, or getting worse

These evaluations will help determine if the treatment should continue as planned

4 Follow-up phase

After completing the main treatment, you will enter a follow-up period

Regular check-ups will continue to monitor your health status

Additional blood tests will be performed to check for any remaining cancer cells

Your quality of life and physical condition will be assessed using special questionnaires

Who Can Join the Study?

Must be at least 18 years old with a confirmed diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma
Must have received at least one previous treatment for the condition, with a minimum of 2 treatment cycles
For patients who received previous BCL2 inhibitor therapy, they must have:
– Received it as first-line treatment
– Had remission for at least 3 years
– Had at least 2 years pass since the last dose
Must meet current treatment criteria according to medical guidelines
Must have an ECOG Performance Status of 0, 1, or 2 (a scale measuring ability to perform daily activities)
Must have adequate bone marrow function, including:
– Sufficient white blood cell counts
– Sufficient platelet counts
– Hemoglobin levels above 75 g/L
Must have adequate liver function, shown by:
– Liver enzyme tests within acceptable limits
– Normal or near-normal bilirubin levels
Must have adequate kidney function, with kidney filtration rate of at least 30 mL/min
Must have a life expectancy of more than 6 months

Who Cannot Join the Study?

Prior treatment with venetoclax (a medication used to treat blood cancers)
History of major organ transplant
Active or untreated central nervous system lymphoma (cancer in brain or spinal cord)
Known HIV infection
Active hepatitis B or C infection
Significant heart conditions including heart failure or recent heart attack
Uncontrolled high blood pressure
Other active cancers requiring treatment (except certain skin cancers)
Pregnancy or breastfeeding
Severe liver or kidney problems
History of other serious medical conditions that could interfere with study participation
Unable to swallow oral medications
Participation in another clinical trial within 28 days
Known allergic reactions to study medications
Major surgery within 4 weeks before starting the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Gemeinschaftspraxis Haematologie Onkologie	Dresden	Germany
ASL di Salerno – PO Andrea tortora	Pagani	Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Medical University Of Vienna	Vienna	Austria
University Hospital Jena KöR	Jena	Germany
Hospital Universitario De Salamanca	Salamanca	Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Ustav Hematologie A krevni Transfuze	Prague	Czechia

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
University Hospital Limerick	Limerick	Ireland
Tergooiziekenhuizen	Hilversum	The Netherlands
Hospital Universitario Infanta Leonor	Madrid	Spain
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu	Torun	Poland
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts	Mutlangen	Germany
Diakonie Klinikum Dietrich Bonhoeffer GmbH	Neubrandenburg	Germany
Haematologisch Onkologische Schwerpunktpraxis	Wuerzburg	Germany
Lund University Hospital	Lund	Sweden
Flevoziekenhuis Stichting	Almere	The Netherlands
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Centre Henri Becquerel	Rouen	France
Odense University Hospital	Odense	Denmark
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Karolinska University Hospital	Solna	Sweden
University Hospital Galway	Galway	Ireland
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse	Vienna	Austria
Aalborg University Hospital	Aalborg	Denmark
Hospital Universitario Virgen De Valme	Sevilla	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
ARNAS G. Brotzu	Cagliari	Italy
Centre Hospitalier Universitaire De Rennes	Rennes	France
Rigshospitalet	Copenhagen	Denmark
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Hospital Costa del Sol	Marbella	Spain
Region Sjaelland	Holbæk	Denmark
Onkologische Schwerpunktpraxis Kurfuerstendamm	Berlin	Germany
Cggpqouhu Ufmpmvhasprdqx Sllqxllti	Woluwe-Saint-Lambert	Belgium
Cgwpue Heatxolgfav Uwhmuwsccxzsz Rakzj	Reims	France
Rfsdigott Zhdanfwwkw Suoyenrtq	Arnhem	The Netherlands
Hefhqhjc Umulehdczhlzz Dd Ls Psshnbgc	Madrid	Spain
Hoggqttm Udorifuefkxip Mvkdvsz Dh Vyhsranrqb	Santander	Spain
Ijsxiwem Chbtsp Dyaynfmrkvanwuxiv	L'hospitalet De Llobregat	Spain
Wtgpgdfjxlu Wrolbqpqrqvlqwrugcai Ctofvnc Ourdxwnkh I Thwepdxkmcgup Ir Mcbdozuqmsi W Laxwm	Lodz	Poland
Ufcdsxyigx Hkiuomqe Cxalolr	Cologne	Germany
Uzpgsiw Unmqvpdioe Hcsbufhl	Uppsala	Sweden
Ceen Dk Nisfp	Vandoeuvre Les Nancy	France
Knzwutbb djb Upmmfumheymu Mdglnyav Ama	Munich	Germany
Uzlgtvhvgagzbm Cbhlhkd Kzdmbzryi	Gdansk	Poland
Uhgjdfqphh Of Aypqlye	Edegem	Belgium
Hhmsargc Vsgh danampfu	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	15.12.2025
Belgium	Recruiting	15.12.2025
Czechia	Recruiting	15.12.2025
Denmark	Recruiting	15.12.2025
France	Recruiting	15.12.2025
Germany	Recruiting	15.12.2025
Ireland	Recruiting	15.12.2025
Italy	Recruiting	15.12.2025
Poland	Recruiting	15.12.2025
Spain	Recruiting	15.12.2025
Sweden	Recruiting	15.12.2025
The Netherlands	Recruiting	15.12.2025

Trial locations

Investigated drugs:

Sonrotoclax is a medication being studied for treating chronic lymphocytic leukemia and small lymphocytic lymphoma in patients whose cancer has returned or did not respond to previous treatments. It belongs to a class of drugs that work by helping to destroy cancer cells.

Obinutuzumab is an antibody therapy that targets specific proteins on cancer cells to help the immune system identify and destroy them. It is given by infusion and is used in combination with other cancer treatments.

Venetoclax is a cancer medication that works by blocking a protein that helps cancer cells survive. It is taken as a tablet and is currently used in treating certain blood cancers.

Rituximab is an antibody therapy that has been used for many years to treat various blood cancers. It works by targeting specific proteins on cancer cells, helping the immune system to recognize and destroy them. It is given by infusion.

Chronic Lymphocytic Leukemia (CLL) – A slow-growing blood cancer that starts in white blood cells called lymphocytes in the bone marrow. These abnormal cells gradually increase and spread into the blood, where they accumulate over time. The disease mainly affects older adults and causes the bone marrow to make too many abnormal lymphocytes, which don’t work properly to fight infection. As these abnormal cells build up in the blood and bone marrow, they leave less room for healthy blood cells. The condition can cause swollen lymph nodes, fatigue, and increased risk of infections.

Small Lymphocytic Lymphoma (SLL) – A type of cancer that affects the lymphocytes, primarily in the lymph nodes. It is essentially the same disease as CLL but differs mainly in where the cancer cells collect. In SLL, the abnormal lymphocytes mainly build up in the lymph nodes, while in CLL they are more common in the blood and bone marrow. The disease causes enlarged lymph nodes and can affect multiple areas of the body where lymph tissue is found. As the condition progresses, it can cause the lymph nodes to grow larger and may affect the body’s ability to fight infections.

Trial ID:

2024-517131-52-00

Protocol code:

BGB-11417-303CLL-RR1

NCT ID:

NCT06943872

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of sonrotoclax plus obinutuzumab or rituximab compared to venetoclax plus rituximab in patients with relapsed or refractory chronic lymphocytic leukemia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?