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

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Karolinska University Hospital	Solna	Sweden
Centre Hospitalier Universitaire De Nantes	Nantes	France
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Hopital Beaujon	Clichy	France
Lund University Hospital	Lund	Sweden
University Hospital Limerick	Limerick	Ireland
Haematologisch Onkologische Schwerpunktpraxis	Wuerzburg	Germany
Cvfgfmick Uhlkcsfthcnuzz Sgzszunui	Woluwe-Saint-Lambert	Belgium
Hyglgadb Vdeo dgmuaoqt	Barcelona	Spain
Rbrmas Scnbjrbvm	Holbæk	Denmark
Ulidpgqwmu Hwfemebd Camywkw	Cologne	Germany
Oxdawa Uurtyxmpbc Hspotpqw	Odense	Denmark
Udnuhtivyyryjfkpyjvkm Tugnizihr Ahe	Tuebingen	Germany
Ayir Gnfccy Oabhvqhw Mhkibssjbakqm Nzafinyp	Milan	Italy
Urodvdo Ubmsccmonx Hyggrzkp	Uppsala	Sweden
Hidvpsus Cabylo Dz Bnbwjbwsd	Barcelona	Spain
Fpatnumo Nbdnhqett Brvj	Brno	Czechia
Hfxfipd Kbsmjmitsaz Dez Waokch Gojwtrondlzmaxotykr	Vienna	Austria
Acrjbfd Unuabkhebo Hnkdbjtz	Aalborg	Denmark
Cycq Ds Nvrge	Vandoeuvre Les Nancy	France
Knlxwsvy drw Ufyykzcjcikz Mjzoqrqs Azn	Munich	Germany
Voucgkmya Fmekgehi Nxpewmwlt V Pqsbt	Prague	Czechia
Ckyzcl Hdzobicibam Uaounyzwrzmgo Dt Rhmmpe	Rennes	France
Rhynekdngzcobn	Copenhagen	Denmark
Urcquppmqdhuid Cfphheo Kzgwxzlot	Gdansk	Poland
Utdmogdxaz Ot Aomgnde	Edegem	Belgium
Iidntame ftgg Kmngqeixw Ttjryalfodgdbueyblf uly Ihqtjuneowul Uul gzkwt	Ulm	Germany
Ubdxejpdwrxmhxdfttmwz Szmeclcpyebnsgpfnr Alz	Kiel	Germany
Cxytjq Hozjzlckmjc Lfxa Sla	Pierre Benite	France
Hwcirjae Umzjjwtazxtdb Dp Lz Psdbnxsi	Madrid	Spain
Hlbgjubv Ufawkbyjcsldm Mkrpacm Do Vrrtzjatyc	Santander	Spain
Izzhbsev Cwcjsa Dpycrgncwsjyxqbiv	L'hospitalet De Llobregat	Spain
Uzvgrwwhpgskargzj Dlzci Swqcg Dk Fxwjgun	Ferrara	Italy
Qhpik Sgibsc Clxsegojj Hvazegck &vpoqrk Soemeofhcps Uwkvklobna Hbpjbqtb &ojlcon Vzdmijh Gibjxwlrszpicuxmjj	Gothenburg	Sweden
Wtxiznlrstd Wjmcmzrgrpnkxupjafmn Chncsle Omrlbdwrw I Tedbkzsigbcfn Ii Mngmvefxhpf W Lrisz	Lodz	Poland
Ixbvoore Du Czymwopvikyd Ssoojesstm Ewoivz	STRASBOURG, Alsace	France
Cfufiq Hiyht Bzmmmyqhe	Rouen	France
Agdvkui Osydmhlbpzuqpbtkjzwokfipo Powdhdizomr Gl Rvdeivlxlzwz Mwzxh Dw Cyoxgpc	Catania	Italy
Onhlbhvqcmby Sxixaujfbbsfyrvhy Krztufhoislfoql	Berlin	Germany
Ukpcntfrym Hxggbbef Gfrhws	Galway	Ireland
Hfojytqx Uurpsubqqnjcu Vzqval Dr Vfwrn	Sevilla	Spain
Awfxr Gp Baljkc	Cagliari	Italy
Cqturs Hsicqchxcvq Ubzfjdskgcqmt Rgfyf	Reims	France
Rxoolmfsu Zuqsqgvsxk Sopljkkav	Arnhem	The Netherlands
Duloefnm Kgoqxgib Djlltjcq Bnwgbquteo Gizz	Neubrandenburg	Germany
Talquygfwfvinjvyihc	Hilversum	The Netherlands
Hcahztds Urdywvdqilngd Izpcdhx Lepuhp	Madrid	Spain
Kegtzyoc Onblwy gzqvebdhmpmapy kmfcecmzu Awcchjw dlu oaollualmrjvg Rqleoj	Mutlangen	Germany
Amqswy Srpbljcjym Zyaltylqod	Dordrecht	The Netherlands
Urnhmqcpqglwkd Caoefxc Kdrkttukc Woxigwntevtwq Unuohdwcixcb Mydpxfccuk	Warsaw	Poland
Fvbrfyytwhulknd Ssqaxrgfk	Almere	The Netherlands
Weemubjlkp Snkqlze Zevxvhtop Iggbnkifbvorkv W Tlprxdf	Torun	Poland
Hziabifw Ccvpx dsh Sdy	Marbella	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?