Study on Acalabrutinib for Very Old or Frail Patients with Chronic Lymphocytic Leukemia

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What is this study about?

This clinical trial is focused on studying the effects of a medication called acalabrutinib on patients with chronic lymphocytic leukemia (CLL). CLL is a type of cancer that affects the blood and bone marrow. The study is specifically looking at patients who are either very old, aged 80 years or older, or considered frail, meaning they have a higher risk of complications from standard treatments. The medication being tested, acalabrutinib, is a small molecule drug that works by inhibiting a protein called Bruton’s tyrosine kinase, which plays a role in the growth of cancer cells.

The purpose of this study is to evaluate how effective acalabrutinib is in treating CLL in this specific group of patients. Participants in the study will receive acalabrutinib in the form of either film-coated tablets or hard capsules, taken orally. The study will last for a period of approximately 24 months, during which the participants’ response to the treatment will be monitored. The study will assess the overall response rate, which refers to how well the cancer responds to the treatment, as well as other factors such as overall survival and progression-free survival, which is the length of time during and after treatment that the patient lives with the disease without it getting worse.

Throughout the study, the safety of acalabrutinib will also be closely monitored, with attention to any adverse events or side effects that may occur. This includes tracking any falls or episodes of confusion, which are common concerns for older patients. The study aims to provide valuable information on the feasibility and safety of using acalabrutinib in treating CLL in older or frail patients, potentially offering a new treatment option for those who may not tolerate more intensive therapies.

1 joining the study

Upon joining the study, the patient will be assessed to ensure they meet the eligibility criteria. This includes being 80 years or older, or having a frailty score greater than 2.

The patient must have documented chronic lymphocytic leukemia (CLL) that requires treatment and must provide written informed consent.

2 treatment initiation

The patient will begin treatment with acalabrutinib, which is available as 100 mg film-coated tablets or hard capsules.

The medication is taken orally. The specific dosage and frequency will be determined by the study protocol and the patient’s condition.

3 initial response assessment

Approximately 6 months after starting therapy, the patient’s response to the treatment will be assessed. This is referred to as the initial response assessment, occurring at cycle 7, day 1.

4 ongoing treatment and monitoring

The patient will continue to receive acalabrutinib and will be monitored regularly for any side effects or changes in their condition.

The study will track various outcomes, including overall survival, progression-free survival, and any adverse events.

5 final restaging

Approximately 24 months after starting therapy, a final restaging will occur to evaluate the patient’s overall response to the treatment. This takes place at cycle 25, day 1.

6 completion of study

The study is expected to conclude by June 30, 2025. At this point, the patient’s participation in the trial will end, and any further treatment decisions will be made based on the study’s findings and the patient’s health status.

Who Can Join the Study?

Must be 80 years or older or considered too frail for standard treatment, as determined by a frailty score greater than 2.
If you had recent treatment, you must have recovered from any immediate side effects, and the treatment must have been stopped for a certain period before starting the study:
- Chemotherapy: at least 28 days before
- Antibody treatment: at least 14 days before
- Kinase inhibitors, BCL2-antagonists, or immuno-modulatory agents: at least 3 days before
- Corticosteroids: can be used until the study starts but must be reduced to 20mg or less of prednisolone per day during treatment
Must have signed an informed consent form and be able to follow the study protocol.
Must have documented chronic lymphocytic leukemia (CLL) that requires treatment according to specific criteria.
Must be willing and able to provide written consent and follow the study visit schedule and other requirements.
Must have a glomerular filtration rate (GFR) greater than 30ml/min, which measures kidney function. Patients on hemodialysis cannot participate.
Must have adequate liver function, shown by specific blood test results, unless the results are due to CLL or a condition called Gilbert’s Syndrome.
Must have adequate bone marrow function without needing growth factors or transfusions, unless low blood counts are due to CLL:
- Neutrophil count: at least 1.0 x 10^9/L
- Platelet count: at least 30 x 10^9/L, or at least 10 x 10^9/L if CLL affects the bone marrow
- Hemoglobin level: at least 9 g/dL without transfusion support, unless anemia is due to CLL
Must test negative for hepatitis B and hepatitis C. If previously exposed to hepatitis B, additional testing is required.
Must have a life expectancy of at least 3 months.
Can have had a maximum of one previous treatment for CLL.

Who Cannot Join the Study?

Patients who have had a recent heart attack or serious heart problems.
Patients with uncontrolled high blood pressure.
Patients with active infections that are not being treated.
Patients who are pregnant or breastfeeding.
Patients with severe liver disease.
Patients who have had another type of cancer in the last 5 years, except for certain skin cancers.
Patients who are allergic to the study medication or similar drugs.
Patients who are currently participating in another clinical trial.
Patients with a history of bleeding disorders.
Patients who have had a stroke in the last 6 months.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Universitaet Innsbruck	Innsbruck	Austria

Other Sites

Site Name	City	Country
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Institut Fuer Versorgungsforschung In Der Onkologie GbR	Koblenz	Germany
OncoResearch Lerchenfeld GmbH	Hamburg	Germany
Haematologisch Onkologische Schwerpunktpraxis	Wuerzburg	Germany
Überörtliche Gemeinschaftspraxis für Hämatologie und Onkologie (GEHO)	Munster	Germany
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse	Vienna	Austria
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH	Paderborn	Germany
Dr. Vehling-Kaiser MVZ GmbH	Landshut	Germany
DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU	Deggendorf	Germany
Studienzentrum Onkologie Ravensburg GmbH	Ravensburg	Germany
Onkologische Schwerpunktpraxis Kurfuerstendamm	Berlin	Germany
Uzqmunshshfrirqhzemrl Evgve Asa	Essen	Germany
Mjuicshopnc Gkb	Hanover	Germany
Ufeihzsrkn Hycmbmhu Cbfouds	Cologne	Germany
Gmgbwyinhkqpqasgtkl fop Hpbwgytrrle uzb Ouuogvwdr	Magdeburg	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.06.2021
Germany	Not recruiting	01.06.2021

Trial locations

Investigated drugs:

Acalabrutinib

Acalabrutinib is a medication used in this clinical trial to treat patients with chronic lymphocytic leukemia (CLL) who are either very old (80 years or older) or considered frail. The trial aims to evaluate how effective acalabrutinib is in these patients by assessing their own health improvements.

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 white blood cells called lymphocytes. 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, symptoms such as fatigue, swollen lymph nodes, and frequent infections may occur. The progression of CLL can vary greatly among individuals, with some experiencing a more aggressive form of the disease.

Trial ID:

2023-507002-14-00

Protocol code:

CLL-Frail

NCT ID:

NCT04883749

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Acalabrutinib for Very Old or Frail Patients with Chronic Lymphocytic Leukemia

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