A study of acalabrutinib and venetoclax for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have relapsed after initial treatment

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What is this study about?

This study focuses on people with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, which is a type of cancer that affects the white blood cells in the body. The research is being conducted to determine how well a combination of two medications works for patients whose disease has returned after receiving an initial treatment. The medicines being studied are acalabrutinib and venetoclax, and some participants may also receive obinutuzumab.

During the study, participants will take these medications as part of a treatment plan. The process involves monitoring the disease to see how the body responds to the combined medicines. The study will follow the participants over time to see how long the treatment keeps the cancer under control and to ensure the medications are being used safely.

Who Can Join the Study?

You must be at least 18 years old when you sign the consent form to join the study.
You must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), which are types of blood and immune system cancers, following specific medical guidelines.
You must have previously received a specific type of initial treatment involving covalent BTKi (a type of targeted drug) and BCL2i (another type of targeted drug), possibly along with obinutuzumab (an immunotherapy drug).
Your previous treatment must have been successful, reaching at least a partial remission (a state where the signs and symptoms of the cancer have decreased) or complete remission (a state where there are no detectable signs of the cancer).
At least 2 years must have passed since you finished your first round of treatment.
Medical tests must be available or completed before starting the study to check for IGHV status (a genetic marker in blood cells), 17p deletion (a missing piece of a chromosome), and TP53 mutation (a change in a specific gene that helps prevent cancer).
You must have an ECOG performance status of 0, 1, or 2, which is a scale used by doctors to measure how well you can perform daily activities and your overall physical health.
Your organs (such as the liver or kidneys) and your bone marrow (the spongy tissue inside bones that makes blood cells) must be functioning well.

Who Cannot Join the Study?

Having any other health problem that the doctor believes would make it unsafe or unwise for you to join the study.
A history of hypersensitivity or anaphylaxis, which are severe allergic reactions to the medications being studied.
The need to take medicines that are strong CYP3A4 inhibitors or inducers, which are drugs that change how your body processes other medications.
The need for, or currently taking, anticoagulation therapy with warfarin or similar vitamin K antagonists, which are medicines used to prevent blood clots by thinning the blood.
Having a major surgery within 30 days before taking the first dose of the study medicine.
Having significant cardiovascular disease (heart problems) or cerebrovascular disease (problems with blood flow to the brain, such as a stroke).
Having active bleeding or a history of bleeding diathesis, which refers to a condition where your blood does not clot normally, such as hemophilia or von Willebrand disease.
Having liver cirrhosis classified as Child-Pugh B or C, which indicates moderate to severe scarring and damage to the liver.
A history of having, or currently having, any other type of malignancy, which is another word for cancer.
Testing positive for HIV, the virus that attacks the body’s immune system.
A history of progressive multifocal leukoencephalopathy (PML), which is a rare and serious infection that affects the brain.
Having an active hepatitis B or hepatitis C infection, which are viruses that cause inflammation of the liver.
Using corticosteroids (steroid medicines used to reduce inflammation) in a dose higher than 20 mg within one week before the first dose of the study medicine.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
University Hospital Ostrava	Ostrava	Czechia
Ospedale San Raffaele S.r.l.	Milan	Italy
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Ayiqxxi Ohtzgseunuc dg Pcqtkc	Padua	Italy
Hpndgisl Vsay dqoxrzxh	Barcelona	Spain
Amev Gsooqf Ozhwunwz Mfyzywwztdfag Nyuvfdik	Milan	Italy
Ioyqpqmh Rzkloapvz Pds Ly Smgyoe Dil Tfxyrz Diss Ahflpcs Ifbw Spcjjh	Meldola	Italy
Fpkkidgw Nfjiigplo Bvax	Brno	Czechia
Hreplbsb Df Ln Sobgh Cwbm I Suku Pjf	Barcelona	Spain
Hxoepqcn Uizgltnccuppc Pepxtn Dq Hqqqbv Df Mzewnizjalk	Majadahonda	Spain
Hnwkzvyn Uaqsmumweiiuq 1r Db Oddcysd	Madrid	Spain
Hfhidxxt Uozknvrevtvyz Vhdnef Dd Lkf Nqhepl	Granada	Spain
Siuvfkv Uctaesylxeibv Nt 2 Ip Dv Jhdw Bydbwzz W Bnlcntxfyr	Bydgoszcz	Poland
Srztskqpnqm Pedaeeiww Shdvmlm Kteafscpm Nf 4 W Ltzkylnu	Lublin	Poland
Aoqolfi Usyry Sopbeutsp Lunpow Dsskt Ruwbhuy	Faenza	Italy
Iptrylrm Hfrtgjzqcug I Tkfpvejaujnvvlr	Warsaw	Poland
Mlp Cgzupvdc Rtzshkie Pdjyiub Bj Plouys	Warsaw	Poland
Hwiszgyv Uthuhkhnkeqev Ikrwojg Lxippp	Madrid	Spain
Nsl Ltp Gxolyxfxsl Wkqdqzogfae Gbzk	Horn	Austria

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	18.05.2026
Czechia	Not yet recruiting	18.05.2026
Ireland	Recruiting	18.05.2026
Italy	Recruiting	18.05.2026
Poland	Not yet recruiting	18.05.2026
Spain	Recruiting	18.05.2026

Trial locations

Investigated Drugs:

Acalabrutinib is a medication used to treat certain types of blood cancers by blocking specific proteins that help cancer cells grow and survive.

Venetoclax is a medication designed to target and help kill cancer cells by interfering with a protein that allows these cells to avoid natural cell death.

Investigated Diseases:

Chronic lymphocytic leukaemia recurrent

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma – This is a type of cancer that involves the abnormal buildup of certain white blood cells called lymphocytes. In the leukemia form, these cells primarily circulate in the blood and bone marrow. In the lymphoma form, the cells tend to accumulate in the lymph nodes and other tissues. The condition typically develops slowly over time as the abnormal cells multiply. As it progresses, the increasing number of these cells can interfere with the normal functioning of the immune system.

Trial ID:

2024-518858-17-00

Protocol code:

D8220C00036

NCT ID:

NCT07024706

Trial Phase:

Therapeutic exploratory (Phase II)

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A study of acalabrutinib and venetoclax for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have relapsed after initial treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?