Study Comparing Acalabrutinib and Venetoclax with Venetoclax and Obinutuzumab for Patients with Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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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), which are types of blood cancers. The study will compare two treatment combinations: one using Acalabrutinib and Venetoclax, and the other using Venetoclax and Obinutuzumab. Acalabrutinib is a medication that helps to block certain proteins that cancer cells need to grow, while Venetoclax works by helping to kill cancer cells. Obinutuzumab is an antibody that targets and destroys cancer cells. The purpose of the study is to determine which combination is more effective in treating these diseases.

Participants in the study will be randomly assigned to receive one of the two treatment combinations. The study will be conducted over a period of time, with regular check-ups to monitor the participants’ health and the effectiveness of the treatment. The medications will be administered either as tablets taken by mouth or as an infusion, which is a method of delivering medication directly into the bloodstream through a vein. The study will also include a group receiving a placebo, which is a substance with no active medication, to help compare the effects of the treatments.

The trial aims to assess various outcomes, such as how long participants live without the disease getting worse, the overall survival rate, and the response to the treatment. Additionally, the study will look at the quality of life of participants and any side effects they may experience. The trial is expected to continue until 2029, providing valuable information on the best treatment options for people with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the participant meets the criteria for the trial.

2 randomization

Participants are randomly assigned to one of two treatment groups. This process ensures that each participant has an equal chance of receiving either treatment option.

3 treatment phase

Participants in the first group receive acalabrutinib and venetoclax. Acalabrutinib is administered as 100 mg film-coated tablets or hard capsules, taken orally. Venetoclax is provided in varying dosages: 10 mg, 50 mg, and 100 mg film-coated tablets, also taken orally.

Participants in the second group receive venetoclax and obinutuzumab. Venetoclax is administered in the same dosages as the first group. Obinutuzumab is given as a 1,000 mg solution for infusion, administered intravenously.

The treatment duration and specific dosage schedule are determined by the study protocol and may vary based on individual response and tolerance.

4 monitoring and assessments

Throughout the trial, regular monitoring and assessments are conducted to evaluate the participant’s response to treatment. This includes blood tests, imaging studies, and other evaluations as required by the study protocol.

The primary goal is to assess progression-free survival, which is the time from randomization until disease progression or death.

5 completion of treatment

After completing the treatment phase, participants undergo a final assessment to evaluate the overall response to the treatment. This includes measuring the rate of undetectable minimal residual disease in the blood and other health outcomes.

6 follow-up

Participants enter a follow-up period where their health and any long-term effects of the treatment are monitored. This phase helps gather additional data on overall survival and event-free survival.

Who Can Join the Study?

Participant must be at least 18 years old at the time of signing the consent form.
Must have documented Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that requires treatment according to specific guidelines. This includes having a detectable group of B-cells at the start for measuring Minimal Residual Disease (MRD).
Must have adequate Bone Marrow (BM) function without needing growth factor or platelet transfusion support within 2 weeks of starting the screening. This means:
- Absolute Neutrophil Count should be at least 1.0 x 10⁹/L, or at least 500 cells/μL if there is documented BM involvement of CLL/SLL.
- Platelet counts should be at least 30 x 10⁹/L, or at least 10 x 10⁹/L if there is documented BM involvement of CLL/SLL.
Must have an estimated Creatinine Clearance (CrCL) of at least 30 mL/min, calculated using a specific formula based on weight and age, or have a serum creatinine level less than 2 times the upper limit of normal.
Must meet certain laboratory parameters:
- Serum AST and ALT levels should be no more than 3 times the upper limit of normal, unless liver issues are due to CLL/SLL.
- Total bilirubin should be no more than 1.5 times the upper limit of normal, unless due to a condition called Gilbert’s syndrome.
Must have an ECOG performance status of 0 to 2, which means being able to carry out daily activities with no significant decline in the two weeks before starting the study or on the day of the first dose.

Who Cannot Join the Study?

Patients who do not have Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma cannot participate.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients are considered for participation, so gender is not an exclusion factor.
Patients who are part of a vulnerable population may not be eligible. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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

No sites found in this category

Other Sites

Site Name	City	Country
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Fakultni Nemocnice Plzen	Plzen	Czechia
Pratia Hematologia Sp. z o.o.	Katowice	Poland
University Of Debrecen	Debrecen	Hungary
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet	Budapest	Hungary
Pratia S.A.	Skorzewo	Poland
In Vivo Sp. z o.o.	Bydgoszcz	Poland
Servei De Salut De Les Illes Balears	Palma	Spain
University Hospital Ostrava	Ostrava	Czechia
Wzvfhhyudpe Whmgvogspnvvdlmolujz Czihsxd Osdfyptvg I Tfkeuyurhaaij Im Mwoeervvrpj W Lpori	Lodz	Poland
Ckpmfj Hfhmqmgliwj Riayxvdg Uqlajgezicokj Dg Tkdrv	Tours	France
Hhuauheq Dt Lj Ssykz Cjso I Svjf Pmg	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	31.05.2022
France	Not recruiting	31.05.2022
Hungary	Not recruiting	31.05.2022
Poland	Not recruiting	31.05.2022
Spain	Not recruiting	31.05.2022

Trial locations

Investigated drugs:

Acalabrutinib is a medication used in this trial to treat chronic lymphocytic leukemia or small lymphocytic lymphoma. It works by blocking a specific protein in cancer cells, which helps to stop the cancer from growing and spreading.

Venetoclax is another medication involved in the trial. It helps to treat leukemia by targeting and blocking a protein that prevents cancer cells from dying, thereby promoting the death of these cells.

Obinutuzumab is used in combination with Venetoclax in this trial. It is a type of antibody therapy that attaches to cancer cells and helps the immune system to destroy them.

Investigated diseases:

Chronic Lymphocytic Leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the production of too many abnormal white blood cells called lymphocytes. These abnormal cells accumulate over time, crowding out healthy blood cells and impairing the immune system. The disease often progresses slowly, and many individuals may not experience symptoms for years. As it advances, symptoms such as fatigue, swollen lymph nodes, and frequent infections may occur. The progression can vary greatly among individuals, with some experiencing a more aggressive form of the disease.

Small Lymphocytic Lymphoma – This is a type of non-Hodgkin lymphoma that is closely related to chronic lymphocytic leukemia, involving the same type of cancerous lymphocytes. It primarily affects the lymph nodes rather than the blood and bone marrow. The disease progresses slowly, often without noticeable symptoms in the early stages. Over time, it can lead to swollen lymph nodes, fatigue, and an increased risk of infections. The progression rate can differ among individuals, with some experiencing a more indolent course.

Trial ID:

2023-505866-27-00

Protocol code:

D8220C00027

NCT ID:

NCT05057494

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Acalabrutinib and Venetoclax with Venetoclax and Obinutuzumab for Patients with Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?