Study Comparing Ibrutinib and Venetoclax with Chlorambucil and Obinutuzumab for First-line Treatment in Patients with Chronic Lymphocytic Leukemia

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What is this study about?

This clinical trial is focused on studying the treatment of Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). These are types of cancer that affect the blood and lymph nodes. The study is comparing two different treatment combinations. One group will receive a combination of Ibrutinib and Venetoclax, while the other group will receive Chlorambucil and Obinutuzumab. Ibrutinib is taken in the form of a capsule, and its code name is JNJ-54179060.

The purpose of this study is to see how well these treatments work in preventing the cancer from getting worse. Participants will be randomly assigned to one of the two treatment groups. The study will be open-label, meaning both the participants and the researchers will know which treatment is being given. The trial will continue for a period of time to monitor the progression of the disease and the effectiveness of the treatments.

Throughout the study, participants will receive regular check-ups and monitoring to ensure their safety and to track the progress of their treatment. The goal is to determine which combination of medications is more effective in managing CLL and SLL, providing valuable information for future treatment options.

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 diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) meets specific criteria.

2 randomization

Participants are randomly assigned to one of two treatment groups. One group receives a combination of ibrutinib and venetoclax, while the other group receives chlorambucil and obinutuzumab.

3 treatment phase

For those receiving ibrutinib, the medication is administered orally in the form of a 140 mg capsule. The dosage and frequency are determined by the study protocol and monitored by the medical team.

Participants receiving venetoclax will follow a specific dosing schedule that gradually increases to minimize side effects. The exact dosage and frequency are provided by the healthcare team.

The alternative treatment group receives chlorambucil and obinutuzumab according to the study’s guidelines, with specific instructions on dosage and administration provided by the medical staff.

4 monitoring and follow-up

Throughout the treatment phase, regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects. This includes blood tests, imaging studies, and other necessary evaluations.

Participants are required to attend scheduled follow-up visits to ensure ongoing assessment of their health status and response to treatment.

5 completion and final assessment

Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall outcomes of the treatment. This includes a comprehensive review of the participant’s health and any changes in their condition.

Who Can Join the Study?

Participants must be adults who are either:
- 65 years old or older, or
- 18 to 64 years old with at least one of the following conditions:
  - A Cumulative Illness Rating Scale (CIRS) score greater than 6. This is a way to measure the overall health and number of illnesses a person has.
  - Creatinine clearance (CrCl) estimated to be less than 70 mL/min. This is a test to see how well the kidneys are working.
Must have a diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that meets specific criteria.
Must have active CLL/SLL that requires treatment, shown by:
- Worsening anemia (low red blood cells) or thrombocytopenia (low platelets), or both.
- Very large or growing spleen, or symptoms from an enlarged spleen.
- Very large or growing lymph nodes, or symptoms from enlarged lymph nodes.
- Increasing number of lymphocytes (a type of white blood cell) by more than 50% over two months, or doubling in less than six months.
- Constitutional symptoms, which include:
  - Unintentional weight loss of 10% or more in the last six months.
  - Significant fatigue, meaning unable to work or do usual activities.
  - Fevers over 100.5°F (38.0°C) for two or more weeks without infection.
  - Night sweats for more than one month without infection.
Must have measurable nodal disease, meaning at least one lymph node larger than 1.5 cm as seen on a CT scan.
Must have an ECOG Performance Status of 2 or less. This is a scale to measure how well a person can perform daily activities.
Must have adequate organ function, which includes:
- An absolute neutrophil count (ANC) of at least 750 cells/μL without support from growth factors. Neutrophils are a type of white blood cell important for fighting infections.
- Platelet count of at least 50,000 cells/μL without transfusion support for at least 7 days before starting the study.
- Hemoglobin level greater than 8.0 g/dL without transfusion support for at least 7 days before starting the study.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels no more than 3 times the upper limit of normal. These are liver enzymes.
- Total bilirubin level no more than 1.5 times the upper limit of normal, unless due to Gilbert’s syndrome, a common and harmless liver condition.
- Estimated creatinine clearance (CrCl) of at least 30 mL/min.

Who Cannot Join the Study?

Patients with other types of cancer besides Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) cannot participate.
Patients who have had a different cancer treatment recently may not be eligible.
Patients with severe heart problems might be excluded.
Patients with uncontrolled infections are not allowed to join the study.
Pregnant or breastfeeding women cannot participate.
Patients with severe liver or kidney problems may be excluded.
Patients who have had an organ transplant might not be eligible.
Patients with a history of certain mental health conditions may be excluded.
Patients who are unable to follow the study procedures might not be allowed to join.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Fakultni Nemocnice Plzen	Plzen	Czechia
Institut Jules Bordet	Anderlecht	Belgium
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Virgen del Rocío University Hospital	Sevilla	Spain
Jessa Ziekenhuis	Hasselt	Belgium
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Rigshospitalet	Copenhagen	Denmark
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Instytut Hematologii I Transfuzjologii	Warsaw	Poland
Hospital Universitario Infanta Leonor	Madrid	Spain
Region Norrbotten	Lulea	Sweden
Flevoziekenhuis Stichting	Almere	The Netherlands
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.	Slupsk	Poland
University Hospital Ostrava	Ostrava	Czechia
Chhwgh Hwgiijedidw Rmjnaurv Uvdexzeppkqhx Dl Thata	Tours	France
Ammjhvzqz Uzw	Amsterdam	The Netherlands
Hweiycyf Dp Ln Snjpe Cmkn I Sfgk Pyh	Barcelona	Spain
Cfarzm Hsvgegmflsi Uizlfihgyudqr Rnsdm	Reims	France
Hdejkmel Unqocvofvrwja Do Ll Pgwxvxrl	Madrid	Spain
Wlebsxuaijx Wmdrubbshbpehfupviph Csluwbv Opwkmqjkl I Tafwigwwgxnua Ii Mnkomjzxdjz W Lxhwa	Lodz	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	30.04.2018
Czechia	Not recruiting	30.04.2018
Denmark	Not recruiting	30.04.2018
France	Not recruiting	30.04.2018
Poland	Not recruiting	30.04.2018
Spain	Not recruiting	30.04.2018
Sweden	Not recruiting	30.04.2018
The Netherlands	Not recruiting	30.04.2018

Trial locations

Investigated drugs:

Ibrutinib

Ibrutinib is a medication used in the treatment of certain types of blood cancers, including chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It works by blocking a specific protein that helps cancer cells grow and divide, thereby slowing down or stopping the progression of the disease.

Venetoclax is a medication that targets and inhibits a protein that helps cancer cells survive. By blocking this protein, venetoclax can help to kill cancer cells and is used in the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

Chlorambucil is a chemotherapy drug used to treat chronic lymphocytic leukemia (CLL) and other types of cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

Obinutuzumab is a type of medication known as a monoclonal antibody. It is used to treat chronic lymphocytic leukemia (CLL) by targeting and attaching to specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells.

Investigated diseases:

Chronic Lymphocytic Leukemia (CLL) – This is a type of cancer that affects the blood and bone marrow, characterized by the production of too many abnormal lymphocytes, a type of white blood cell. Over time, these abnormal cells accumulate in the blood and bone marrow, crowding out healthy blood cells. CLL progresses slowly in most cases, and individuals may not experience symptoms for years. As the disease advances, it can lead to swollen lymph nodes, fatigue, and an increased risk of infections. The progression of CLL can vary greatly among individuals, with some experiencing a more aggressive form of the disease.

Small Lymphocytic Lymphoma (SLL) – This is a type of non-Hodgkin lymphoma that primarily affects the lymph nodes, but it is closely related to chronic lymphocytic leukemia. In SLL, the abnormal lymphocytes are mainly found in the lymph nodes, causing them to become enlarged. The disease progresses slowly, and symptoms may not appear for a long time. As it advances, SLL can lead to symptoms such as swollen lymph nodes, fatigue, and night sweats. The progression of SLL is similar to CLL, with the potential for the disease to become more aggressive over time.

Trial ID:

2023-503469-49-00

Protocol code:

54179060CLL3011

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Ibrutinib and Venetoclax with Chlorambucil and Obinutuzumab for First-line Treatment in Patients with Chronic Lymphocytic Leukemia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?