Study on Obinutuzumab, Chlorambucil, and Acalabrutinib for Patients with Untreated Chronic Lymphocytic Leukemia

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What is this study about?

This clinical trial is focused on studying treatments for Chronic Lymphocytic Leukemia (CLL), a type of cancer that affects the blood and bone marrow. The study involves three different treatment approaches. The first approach combines Obinutuzumab, a medication given through an infusion into the vein, with Chlorambucil, a chemotherapy drug taken as a tablet. The second approach combines Obinutuzumab with Acalabrutinib (also known as ACP-196), a medication taken orally as a tablet or capsule. The third approach uses Acalabrutinib alone as a monotherapy.

The purpose of the study is to evaluate the effectiveness of these treatments in people who have not received prior treatment for their CLL. Participants will be randomly assigned to one of the three treatment groups. The study will monitor the progress of the disease and the response to the treatment over a period of time. Participants will receive regular check-ups and assessments to track their health and any changes in their condition.

The study aims to provide valuable information on how well these treatments work in managing CLL and to compare their effectiveness. Participants will be closely monitored for any side effects or adverse reactions to the treatments. The study will help in understanding which treatment option might be the most beneficial for patients with CLL.

1 joining the study

Upon joining the study, participants are assigned to one of three groups, known as arms. Each arm involves a different treatment plan for chronic lymphocytic leukemia.

2 treatment arm A

Participants in Arm A receive a combination of obinutuzumab and chlorambucil. Obinutuzumab is administered as an intravenous infusion, while chlorambucil is taken orally as a tablet.

3 treatment arm B

Participants in Arm B receive a combination of acalabrutinib and obinutuzumab. Acalabrutinib is taken orally in the form of a capsule, and obinutuzumab is given as an intravenous infusion.

4 treatment arm C

Participants in Arm C receive acalabrutinib alone. This medication is taken orally in the form of a capsule.

5 medication dosage and frequency

The specific dosage and frequency of each medication are determined by the study protocol and are based on the participant’s health status and response to treatment.

6 monitoring and assessments

Throughout the study, participants undergo regular monitoring and assessments to evaluate the effectiveness of the treatment and to check for any side effects. This includes laboratory tests and possibly imaging studies.

7 study duration

The study is expected to continue until September 2025. Participants will be involved in the study for the duration specified in their treatment plan, which may vary depending on their response to the treatment.

Who Can Join the Study?

Men and women who are 65 years or older, or between 18 and 64 years old if they meet certain health criteria.
Have a specific level of kidney function, measured by a test called the Cockcroft-Gault equation.
Have a score higher than 6 on a health assessment called the Cumulative Illness Rating Scale-Geriatric (CIRS-G).
Have an ECOG performance status of 0, 1, or 2, which is a scale that measures how well a person can perform daily activities.
Have a diagnosis of CD20+ Chronic Lymphocytic Leukemia (CLL), which is a type of blood cancer.
Have active disease that meets at least one of the following criteria for needing treatment:
- Worsening anemia (low red blood cells) or thrombocytopenia (low platelets).
- Enlarged spleen or lymph nodes that are getting bigger or causing symptoms.
- Increasing number of white blood cells over a short period.
- Autoimmune anemia or thrombocytopenia not responding well to standard treatment.
- Symptoms like significant weight loss, fatigue, fever, or night sweats without infection.
Meet certain blood test requirements, such as having enough neutrophils (a type of white blood cell) and platelets.
Have liver function tests within a certain range.
Have kidney function that is at least a certain level.
Be able to attend all outpatient treatments, lab tests, and scans.
Women who can have children must use effective birth control during the study and for a specified time after the last dose of medication.
Men who can father children must use effective birth control during the study and for a specified time after the last dose of medication.
Men must not donate sperm during the study and for a specified time after the last dose of medication.
Be willing and able to follow the study schedule and requirements, and provide written consent to participate.

Who Cannot Join the Study?

Patients who have received treatment for Chronic Lymphocytic Leukemia before cannot participate. This means if you have already been treated for this type of leukemia, you are not eligible.
Patients with other serious health conditions that might interfere with the study are not eligible. This means if you have another major illness, you might not be able to join.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Patients who are unable to follow the study procedures or attend the required visits are not eligible. This means if you cannot commit to the study schedule, you cannot join.
Patients with a history of severe allergic reactions to the study medications cannot participate. This is to prevent any serious health risks.
Patients who are currently participating in another clinical trial are not eligible. This is to avoid any interference with the study results.

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
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Orszagos Onkologiai Intezet	Budapest	Hungary
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.	Slupsk	Poland
Haematologisch Onkologische Schwerpunktpraxis	Wuerzburg	Germany
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
University Of Debrecen	Debrecen	Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
SLK-Kliniken Heilbronn GmbH	Heilbronn	Germany
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Semmelweis University	Budapest	Hungary
San Raffaele Scientific Institute	Milan	Italy
Gasthuiszusters Antwerpen	Antwerp	Belgium
Pratia S.A.	Skorzewo	Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Klaipedos universiteto ligonine VšĮ	Klaipeda	Lithuania
Hopital Beaujon	Clichy	France
Universita Degli Studi Di Brescia	Brescia	Italy
Cprwmgrsn Ugrtepbzdyorsr Sxelcmwkv	Woluwe-Saint-Lambert	Belgium
Aczbxav Odjmyesmsun Unxxwaeytjswm Pnajx	Parma	Italy
Wnilftpdmhg Wmiuxmodwteslnvjgoym Ccticpb Odytepjjp I Tvfwiomztpmdc Il Mvrinzkanzs W Lsrwb	Lodz	Poland
Sjqsalpa Pjbiuqkpw Sxk z owpe	Gdynia	Poland
Lyihuwxk siysgyitv mokdfuv urusudufcyha liuodchlz Krvrs kwaojksw	Kaunas	Lithuania
Sqmibnn Wakdkylmqo W Okfwq Smq z odih	Opole	Poland
Ohtjtinuhrky Srpgahoxldjlhpfhk	Bielefeld	Germany
Isgvbewd Retzxanwj Pmq Lg Shcjwz Dfb Typqho Dbau Awdkiiu Ifuw Sgcwjw	Meldola	Italy
Alcovse Okccaktevqa Nyoevijkh Ss Axecybq E Bgcfok E C Ardyix Akjkfcoicex	Alexandria	Italy
Hexmqfao Dz Lp Sjlye Ctva I Sulk Phv	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.06.2015
France	Not recruiting	01.06.2015
Germany	Not recruiting	01.06.2015
Hungary	Not recruiting	01.06.2015
Italy	Not recruiting	01.06.2015
Lithuania	Not recruiting	01.06.2015
Poland	Not recruiting	01.06.2015
Spain	Not recruiting	01.06.2015
Sweden	Not recruiting	01.06.2015

Trial locations

Investigated drugs:

Obinutuzumab is a medication used in this trial to treat chronic lymphocytic leukemia (CLL). It is a type of antibody therapy that helps the immune system target and destroy cancer cells. In this study, it is used in combination with other treatments to evaluate its effectiveness.

Chlorambucil is a chemotherapy drug that is used to treat CLL. It works by slowing or stopping the growth of cancer cells. In this trial, chlorambucil is combined with obinutuzumab to assess their combined effect on the disease.

ACP-196, also known as acalabrutinib, is a medication used in this study to treat CLL. It is a type of targeted therapy that blocks certain proteins needed by cancer cells to grow. In the trial, acalabrutinib is tested both in combination with obinutuzumab and as a standalone treatment to determine its effectiveness in managing the disease.

Investigated diseases:

Chronic lymphocytic leukaemia

Chronic Lymphocytic Leukemia – Chronic Lymphocytic Leukemia (CLL) is a type of cancer that affects the blood and bone marrow. It is characterized by the production of an excessive number of abnormal lymphocytes, a type of white blood cell. These abnormal cells accumulate over time, crowding out healthy blood cells and impairing the immune system. CLL typically progresses slowly, and many individuals may not experience symptoms for years. As the disease advances, it can lead to symptoms such as fatigue, swollen lymph nodes, and an increased risk of infections. The progression of CLL varies among individuals, with some experiencing a more aggressive form of the disease.

Trial ID:

2023-509348-84-00

Protocol code:

ACE-CL-007

NCT ID:

NCT02475681

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Obinutuzumab, Chlorambucil, and Acalabrutinib for Patients with Untreated Chronic Lymphocytic Leukemia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?