Study of Acalabrutinib for Patients with Chronic Lymphocytic Leukemia

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What is this study about?

This clinical trial is focused on studying Chronic Lymphocytic Leukemia (CLL), a type of cancer that affects the blood and bone marrow. The treatment being tested is a medication called Acalabrutinib, also known by its code name ACP-196. This medication is taken in the form of hard capsules. The purpose of the study is to evaluate how safe and tolerable this treatment is for patients who have either not been treated before or have experienced a return or persistence of their disease after previous treatments.

Participants in the study will take Acalabrutinib orally, meaning they will swallow the capsules. The study will observe how patients respond to the treatment over a period of time, monitoring for any side effects or changes in their condition. The study aims to gather information on the frequency and severity of any adverse effects, including serious ones like heart rhythm problems or liver issues, as well as how the treatment affects the progression of the disease.

The study will also look at how long patients respond to the treatment and how long they can go without the disease getting worse. This information will help determine the overall effectiveness of Acalabrutinib for treating Chronic Lymphocytic Leukemia. The trial is designed to provide valuable insights into the potential benefits and risks of using this medication for patients with this type of leukemia.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose, procedures, and potential risks and benefits. Written informed consent is required to proceed.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes a review of medical history, physical examination, and necessary laboratory tests to ensure the participant meets the study criteria.

3 treatment initiation

The participant will begin treatment with Calquence 100 mg hard capsules, containing the active substance acalabrutinib. The medication is taken orally.

4 medication schedule

The participant will take acalabrutinib as prescribed, typically one capsule twice daily. The exact dosage and frequency will be confirmed by the study team.

5 ongoing monitoring

Regular visits will be scheduled to monitor the participant’s health and response to treatment. This includes physical exams, blood tests, and other assessments as needed.

6 safety and tolerability evaluation

The study aims to evaluate the safety and tolerability of acalabrutinib. Any side effects or adverse events will be recorded and assessed throughout the trial.

7 completion of treatment

The treatment phase will continue until the study’s end date or until the participant is advised to stop for medical reasons. The estimated end date for the trial is September 1, 2025.

8 final assessment

A final assessment will be conducted to evaluate the overall response to the treatment and any long-term effects. This includes a comprehensive review of the participant’s health status.

Who Can Join the Study?

Men and women who are at least 18 years old (or the legal age of consent where the study is taking place).
Must have a diagnosis of chronic lymphocytic leukemia (CLL) that meets specific criteria, including certain types of B-cells and a specific number of B lymphocytes in the blood.
Must have active disease based on certain criteria, such as worsening anemia (low red blood cells) or thrombocytopenia (low platelets), large or growing spleen or lymph nodes, increasing lymphocyte count, or specific symptoms like weight loss, fatigue, fever, or night sweats.
Must meet one of the following:
- Have not received prior treatment for CLL and meet certain health criteria.
- Have received treatment for CLL before and have either refractory (not responding to treatment) or relapsed (disease returned) CLL.
- Have received prior ibrutinib therapy (a type of medication) for CLL.
Must have an ECOG performance status of 2 or less, which is a measure of daily living abilities.
Female participants who can have children must use at least one highly effective method of birth control if sexually active with a male partner, starting from the screening period and continuing for 2 days after the last dose of the study drug.
Must have certain genetic tests done within 60 days before the first dose, including tests for specific genetic deletions and mutations.
Must be willing and able to follow the study schedule, understand and comply with the study requirements, and provide written consent to participate and share health information.

Who Cannot Join the Study?

Patients with other types of cancer besides chronic lymphocytic leukemia cannot participate. Chronic lymphocytic leukemia is a type of cancer that affects the blood and bone marrow.
Patients who have serious heart problems are not eligible. This includes conditions like heart failure or recent heart attacks.
Patients with uncontrolled infections, meaning infections that are not being managed well with treatment, cannot join the study.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients who have had another cancer in the past, unless it was a type that is not expected to come back, are excluded.
Patients who have had a major surgery within the last 4 weeks are not eligible.
Patients who are currently taking certain medications that might interfere with the study treatment cannot participate.
Patients with a history of severe allergic reactions to similar drugs are excluded.
Patients with severe liver or kidney disease are not eligible to join the study.
Patients who have participated in another clinical trial within the last 30 days are not 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	Status
Kuopio University Hospital	Kuopio	Finland
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Universita Cattolica Del Sacro Cuore	Rome	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
St. Olavs Hospital HF	Trondheim	Norway
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Haematologie und Onkologie Muenchen-Pasing MVZ GmbH	Munich	Germany
Region Norrbotten	Lulea	Sweden
Diakonie-Klinikum Schwaebisch Hall gGmbH	Schwäbisch Hall	Germany
Odense University Hospital	Odense	Denmark
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Hospital Clinic De Barcelona	Barcelona	Spain
Klinikum Aschaffenburg-Alzenau gGmbH	Aschaffenburg	Germany
Saarland University Hospital	Homburg	Germany
Aalborg University Hospital	Aalborg	Denmark
Hospital Universitario Araba	Vitoria	Spain
Rigshospitalet	Copenhagen	Denmark
Pirkanmaan hyvinvointialue	Tampere	Finland
Hospital Costa del Sol	Marbella	Spain
Region Sjaelland	Holbæk	Denmark
Cgkfbr Hciwgipgfqq Upmiqyvviwxtg Rmcre	Reims	France
Uhbovaaybjeerwziaepro Eolmn Acm	Essen	Germany
Ufuxrtmalp Dmcva Sreyf Dn Rxeo Lr Sehbzcvm	Rome	Italy
Znsgstd fkpp Hajvxvhxxzjg ubu Ogiwnjyxe Mmg Gakk	Porta Westfalica	Germany
Akbhjnin Uoiamifmnd Hugcammh	Lorenskog	Norway
Ufhhpsy Umwbjrmvqz Hrrfwnfr	Uppsala	Sweden
Hfyec Bwogeg Hg	Bergen	Norway
Hydeqaqh Usllxvumjz Cjrusjf Hspfiaez	Helsinki	Finland
Aiqgzp Uxyravnvkt Huxsfjmz	Aarhus	Denmark
Cesgzo Hmvctdacypk Rdidmbis Ukpsubimxhnwa Dn Twrzc	Tours	France
Cfuj Do Nqyox	Vandoeuvre Les Nancy	France
Upgwfgbtqp Mqavs Gckttkw Oy Cimxwttrg	Catanzaro	Italy

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	13.12.2019
Finland	Not recruiting	13.12.2019
France	Not recruiting	13.12.2019
Germany	Not recruiting	13.12.2019
Italy	Not recruiting	13.12.2019
Norway	Not recruiting	13.12.2019
Spain	Not recruiting	13.12.2019
Sweden	Not recruiting	13.12.2019
The Netherlands	Not recruiting	13.12.2019

Trial locations

Investigated drugs:

Acalabrutinib

Acalabrutinib is a medication used in this clinical trial to treat patients with chronic lymphocytic leukemia. It is being studied to understand how safe and tolerable it is for people who have not received treatment before or for those whose cancer has returned or not responded to previous treatments. Acalabrutinib works by targeting specific proteins in cancer cells, which may help to slow down or stop the growth of the cancer.

Investigated diseases:

Chronic lymphocytic leukaemia

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’s ability to function properly. The disease often progresses slowly, and many people may not experience symptoms for years. As it advances, individuals may notice symptoms such as fatigue, swollen lymph nodes, and frequent infections. The progression can vary greatly among individuals, with some experiencing a more aggressive form of the disease.

Trial ID:

2023-507669-24-00

Protocol code:

D8220C00008

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Acalabrutinib for Patients with Chronic Lymphocytic Leukemia

What is this study about?

Who Can Join the Study?

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