Study of ibrutinib and venetoclax combination therapy for patients with relapsed or refractory chronic lymphocytic leukemia who have adequate kidney function

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What is this study about?

This clinical trial focuses on patients with chronic lymphocytic leukemia (CLL) that has returned or not responded to previous treatments. CLL is a type of blood cancer that affects white blood cells called lymphocytes. The study tests a combination of two medications: ibrutinib and venetoclax, both taken as oral tablets.

The purpose of this study is to determine how well this drug combination works in treating CLL patients, particularly looking at how long patients remain free from disease progression after stopping treatment. The medications work in different ways to fight cancer cells – ibrutinib blocks certain proteins that help cancer cells survive, while venetoclax helps destroy cancer cells by targeting a different protein.

During the study, patients will receive both medications for a specified period. After the initial treatment period, some patients may stop treatment while others continue, based on how well they respond. The study will monitor patients to see if and when they need to restart treatment. Throughout the study, doctors will regularly check patients’ blood and bone marrow to measure the amount of cancer cells remaining in the body.

1 Initial treatment phase

You will begin taking two medications: ibrutinib and venetoclax. Both medications are taken by mouth.

Treatment consists of taking Imbruvica (ibrutinib) 140 mg capsules and Venclyxto (venetoclax) tablets, which come in 10 mg, 50 mg, and 100 mg strengths.

This initial phase of treatment continues for 15 cycles

2 Response evaluation

Your response to treatment will be checked after cycles 3, 9, 12, and 15

Blood tests will be performed to measure the level of minimal residual disease (MRD) – the amount of cancer cells remaining in your body

A bone marrow sample will be taken on day 15 of cycle 15

3 Treatment continuation decision

After the initial treatment phase, you may be assigned to either continue or stop treatment

If treatment is stopped, your condition will be monitored for at least 12 months

If needed, treatment may be restarted based on blood test results

4 Long-term follow-up

Your health will be monitored for up to 3 years after stopping treatment

Regular evaluations will include blood tests and physical examinations

Quality of life assessments will be conducted using questionnaires

5 Safety monitoring

Throughout the study, you will be monitored for any side effects or complications

Regular tests will check your kidney and liver function

Monthly tests for hepatitis B will be performed if applicable

Who Can Join the Study?

Must be at least 18 years old
Must have confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has returned after previous treatment or did not respond to treatment
Must be able and willing to provide written consent to participate in the study
Must have adequate bone marrow function, unless poor function is directly caused by leukemia cells in the bone marrow
Must have adequate kidney function with creatinine clearance of at least 30 mL/min (a measure of how well kidneys filter blood)
Must have adequate liver function
Must test negative for hepatitis B surface antigen and hepatitis C RNA. Patients with certain hepatitis B antibodies may participate if they have negative DNA test results
Must use effective birth control methods during treatment and for 90 days after the last dose of study medication if able to have children
Women who can become pregnant must have a negative pregnancy test before starting the study
Must have a WHO/ECOG performance status of 0-3 (a scale measuring daily living abilities, where 0 means fully active and 3 means capable of only limited self-care)

Who Cannot Join the Study?

Age under 18 years or over 75 years
Previous treatment for chronic lymphocytic leukemia (a type of blood cancer affecting white blood cells)
Known allergies or severe reactions to ibrutinib or venetoclax (the study medications)
Active or uncontrolled infections
Significant heart problems or uncontrolled heart conditions
Severe liver or kidney dysfunction
Other active cancers requiring treatment
Pregnancy or breastfeeding
Participation in other clinical trials within 30 days before starting this study
Mental conditions that could interfere with following study procedures
Any condition that, in the opinion of the study doctor, would make participation unsafe
Unable to provide informed consent
Taking medications that could interact with the study drugs
History of major bleeding disorders
Uncontrolled high blood pressure

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Haga Hospital	Hague	The Netherlands
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Region Oestergoetland	Linkoping	Sweden
Isala Klinieken Stichting	Zwolle	The Netherlands
Groene Hart Ziekenhuis	Gouda	The Netherlands
Canisius Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
Amphia Hospital	Breda	The Netherlands
St. Olavs Hospital HF	Trondheim	Norway
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen	Boras	Sweden
Bernhoven B.V.	Uden	The Netherlands
Odense University Hospital	Odense	Denmark
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Maasstad Ziekenhuis Stichting	Rotterdam	The Netherlands
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Meander Medical Center	Amersfoort	The Netherlands
Turku University Hospital	Turku	Finland
Aalborg University Hospital	Aalborg	Denmark
Gasthuiszusters Antwerpen	Antwerp	Belgium
Reinier de Graaf Groep	Delft	The Netherlands
Zaans Medisch Centrum Stichting	Zaandam	The Netherlands
Region Midtjylland	Aarhus	Denmark
Rigshospitalet	Copenhagen	Denmark
Pirkanmaan hyvinvointialue	Tampere	Finland
Region Sjaelland	Holbæk	Denmark
Cogwyrzri Ukllpqrbqwxicf Sowhqpjkf	Woluwe-Saint-Lambert	Belgium
Rvytyykeo Zszwdblzfs Sdtixljfl	Arnhem	The Netherlands
Uobzbzimkewc Msthize Cpbslcy Gygbkhuwg	Groningen	The Netherlands
Skcbnxceoy srmzydn	Lulea	Sweden
Huavhs Hdcizzgy	Herlev	Denmark
Ajxslvtcg Urn	Amsterdam	The Netherlands
Aorqcwlz Uvgjlghlfm Hqhwcsig	Lorenskog	Norway
Uxqrent Uviklaandw Hpstaphd	Uppsala	Sweden
Hpkqhtsw Uvzdhftvgf Cotcyyg Hnaqzihf	Helsinki	Finland
Egaawib Uogmelzgsobk Mnuqsep Couynzw Reqqnrlhw (ienpvut Mqk	Rotterdam	The Netherlands
Spo Eiyidijxc Hgzxcrlm Twohedq	Tilburg	The Netherlands
Aicyybllv Uky	Amsterdam	The Netherlands
Hwvebqw Jdnfijdn	Haine-Saint-Paul	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	12.07.2017
Denmark	Not recruiting	12.07.2017
Finland	Not recruiting	12.07.2017
Norway	Not recruiting	12.07.2017
Sweden	Not recruiting	12.07.2017
The Netherlands	Not recruiting	12.07.2017

Trial locations

Investigated drugs:

Ibrutinib is a medication that works by blocking a specific protein in cancer cells, helping to stop their growth and survival. It is taken by mouth and is used to treat chronic lymphocytic leukemia (CLL). This medication belongs to a class of drugs called BTK inhibitors, which help control the growth of abnormal white blood cells.

Venetoclax is an oral medication that works by blocking a protein called BCL-2, which helps cancer cells survive. By blocking this protein, venetoclax helps trigger cancer cell death. It is used in the treatment of chronic lymphocytic leukemia and works differently from ibrutinib, providing a complementary approach to treating the disease.

The combination of these two medications is being studied to see how well they work together in treating patients who have relapsed or refractory chronic lymphocytic leukemia, including those with specific genetic changes (TP53 aberrations).

Chronic Lymphocytic Leukemia – A type of blood cancer that starts in white blood cells called lymphocytes in the bone marrow. The disease develops when the bone marrow makes too many abnormal lymphocytes that don’t work properly. These abnormal cells gradually multiply and replace normal white blood cells, making it harder for the body to fight infections. The condition usually develops slowly over months or years, and many people don’t have symptoms in the early stages. As the disease progresses, it can cause swollen lymph nodes, fatigue, and increased susceptibility to infections. This condition primarily affects older adults.

Trial ID:

2023-510557-42-00

Protocol code:

HO141

NCT ID:

NCT03226301

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of ibrutinib and venetoclax combination therapy for patients with relapsed or refractory chronic lymphocytic leukemia who have adequate kidney function

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?