Study on the Effects of Acalabrutinib in Patients with Chronic Lymphocytic Leukemia, Richter’s Syndrome, or Prolymphocytic Leukemia

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What is this study about?

This clinical trial is focused on studying the effects of a medication called acalabrutinib, also known by its code name ACP-196. The trial is designed to explore its use in treating certain types of blood cancers, specifically Chronic Lymphocytic Leukemia (CLL), Richter’s Syndrome, and Prolymphocytic Leukemia. These are conditions where the body produces abnormal white blood cells, which can affect the immune system and overall health. The medication is provided in two forms: film-coated tablets and hard capsules, both taken orally.

The purpose of the study is to determine the safety and appropriate dosage of acalabrutinib for patients with these conditions. Participants in the trial will receive the medication in increasing doses to find the most effective and safe amount. The study will also look at how the body processes the medication and its effects on the disease. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects.

Throughout the study, participants will be monitored closely to observe how their bodies respond to the treatment. This includes regular check-ups and tests to ensure their safety and to gather information on the medication’s impact. The trial aims to provide valuable insights into the potential benefits of acalabrutinib for treating these specific types of leukemia and related conditions.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

Eligibility criteria include being 18 years or older with a confirmed diagnosis of chronic lymphocytic leukemia (CLL), prolymphocytic leukemia, or Richter’s syndrome. The disease must have relapsed after or been resistant to at least two previous treatments.

2 treatment initiation

The treatment involves taking acalabrutinib, which is available as Calquence 100 mg film-coated tablets or hard capsules.

The medication is taken orally. The specific dosage and frequency are determined based on individual needs and the study protocol.

3 dose escalation

The study is designed to explore the effects of increased doses of acalabrutinib. The dose may be adjusted over time to find the most effective and safe level.

Regular monitoring is conducted to assess the body’s response to the medication and to identify any side effects.

4 ongoing monitoring

Throughout the study, regular check-ups are scheduled to monitor health status and the effectiveness of the treatment.

These check-ups include blood tests and other evaluations to measure the response to the medication and to ensure safety.

5 study completion

The study is expected to continue until June 2027. Participants will be involved in the study until its completion or until it is determined that they should discontinue for health reasons.

Upon completion, a final assessment is conducted to evaluate the overall response to the treatment and any long-term effects.

Who Can Join the Study?

Men and women who are 18 years or older with a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), which has come back or not responded after at least 2 previous treatments.
For certain treatment groups: Men and women 18 years or older with Richter’s Syndrome or Prolymphocytic Leukemia transformation, confirmed by a biopsy.
For another treatment group: Men and women 18 years or older with CLL/SLL who did not respond well to ibrutinib treatment or whose condition is getting worse after initially responding to ibrutinib.
Must have CLL/SLL that can be measured, defined as having at least one lymph node that is 2 cm or larger.
Must 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).
- Very large or worsening spleen or lymph nodes.
- Increasing number of lymphocytes (a type of white blood cell) in the blood.
- Autoimmune anemia or thrombocytopenia not responding to standard treatment.
- Symptoms like unintentional weight loss, high fevers, or night sweats without infection.
ECOG performance status of 2 or less, which means the person is able to carry out all self-care but unable to carry out any work activities.
Agreement to use highly effective birth control methods during the study and for 2 days after the last dose if sexually active and able to have children.
Willing and able to participate in all required evaluations and procedures, including swallowing capsules or tablets without difficulty.
Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
For treatment-naive group: Men and women 18 years or older with CLL/SLL who need treatment but do not want or cannot have chemoimmunotherapy.
For ibrutinib intolerant group: Men and women 18 years or older with CLL/SLL who cannot tolerate ibrutinib due to side effects.

Who Cannot Join the Study?

Patients with Chronic Lymphocytic Leukemia cannot participate. This is a type of cancer that affects the blood and bone marrow.
Patients with Prolymphocytic Leukemia are excluded. This is a rare type of leukemia that progresses quickly.
Patients with Richter’s Syndrome cannot join. This is a condition where chronic lymphocytic leukemia changes into a more aggressive form of lymphoma.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ospedale San Raffaele S.r.l.	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	28.05.2015

Trial locations

Investigated drugs:

Acalabrutinib

Acalabrutinib is a medication being studied for its safety and effectiveness in treating certain types of leukemia, including Chronic Lymphocytic Leukemia (CLL), Richter’s Syndrome, and Prolymphocytic Leukemia. It is taken orally and the study aims to find the safest dose that can be given to patients. The study also looks at how the body processes the medication and identifies its major breakdown products.

Investigated diseases:

Richter's syndrome

Chronic Lymphocytic Leukemia – 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. It progresses slowly and may not cause symptoms for years. Over time, it can lead to swollen lymph nodes, fatigue, and an increased risk of infections.

Prolymphocytic Leukemia – This is a rare and aggressive form of leukemia that involves the overproduction of immature white blood cells called prolymphocytes. It progresses more rapidly than chronic lymphocytic leukemia and can cause symptoms such as enlarged spleen, liver, and lymph nodes, as well as fatigue and weight loss.

Richter’s Syndrome – This condition occurs when chronic lymphocytic leukemia transforms into a more aggressive form of lymphoma. It is characterized by a sudden worsening of symptoms, including rapidly enlarging lymph nodes, fever, and night sweats. The progression is typically swift, requiring prompt medical attention.

Trial ID:

2023-509346-35-00

Protocol code:

ACE-CL-001

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Effects of Acalabrutinib in Patients with Chronic Lymphocytic Leukemia, Richter’s Syndrome, or Prolymphocytic Leukemia

What is this study about?

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