Study of Acalabrutinib for Patients with Waldenström Macroglobulinemia

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What is this study about?

This clinical trial is focused on studying Waldenström Macroglobulinemia, a rare type of cancer that affects white blood cells. The treatment being tested in this study is called acalabrutinib, which is available in two forms: 100 mg film-coated tablets and 100 mg hard capsules. The purpose of the study is to evaluate how well acalabrutinib works in treating patients with Waldenström Macroglobulinemia.

Participants in the study will take acalabrutinib orally, meaning they will swallow the tablets or capsules. The study is designed to observe the effects of the medication over a period of time, with regular check-ups to monitor the participants’ health and response to the treatment. The study aims to understand the overall response rate, which refers to how well the cancer responds to the treatment, as assessed by the study investigators.

Throughout the study, researchers will also look at other important factors such as the duration of response, progression-free survival, and overall survival. These terms refer to how long the treatment continues to work, how long patients live without the disease getting worse, and the overall lifespan of the participants, respectively. Additionally, the study will assess the safety of acalabrutinib by monitoring any side effects and how they affect the participants’ quality of life. The study is open-label, meaning both the researchers and participants know which treatment is being administered.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, previous treatments, and current health status.

Participants must have a confirmed diagnosis of Waldenström Macroglobulinemia (WM) and meet other health-related requirements.

2 medication administration

Participants will receive acalabrutinib, which is available as Calquence 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 investigator.

3 treatment duration

The treatment will continue as per the study’s schedule, which is designed to assess the effectiveness and safety of acalabrutinib in treating WM.

Participants will be monitored regularly to evaluate their response to the treatment and any side effects.

4 monitoring and assessments

Regular assessments will be conducted to monitor the overall response rate (ORR) and other health parameters.

These assessments include measuring serum immunoglobulin levels and evaluating the effect of acalabrutinib on immune cell counts.

5 study completion

The study is expected to conclude by October 31, 2026.

Upon completion, the data collected will be analyzed to determine the efficacy and safety of acalabrutinib for treating WM.

Who Can Join the Study?

Men and women who are 18 years or older.
For those who have been treated before: Must have a confirmed diagnosis of Waldenström Macroglobulinemia (WM), which has come back or not responded to at least one previous treatment and needs treatment again.
For those who have not been treated before: Must have a confirmed diagnosis of WM that has not been treated before, needs treatment, and either do not want chemotherapy combined with immunotherapy or have other health issues that prevent them from receiving such treatment. This includes having symptoms like hyperviscosity (thick blood) with IgM levels of 5,000 mg/dL or higher, or nerve problems related to the disease.
Must have a serum IgM concentration (a type of protein in the blood) that is higher than normal, or have measurable nodal WM, which means having at least one lymph node that is 2.0 cm or larger in one direction and 1.0 cm or larger in another direction.
Must have an ECOG performance status of 2 or less. This is a scale that measures how well a person can perform daily activities, with lower numbers indicating better ability.
Women who are sexually active and can have children must agree to use highly effective birth control methods during the study and for 2 days after the last dose of the study medication.
Must be willing and able to participate in all required evaluations and procedures, including swallowing capsules or tablets without difficulty.
Must be able to understand the purpose and risks of the study and provide signed and dated informed consent, allowing the use of their health information according to privacy regulations.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Waldenström Macroglobulinemia. This is a specific type of blood cancer.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have an allergy or severe reaction to the study medication or similar drugs.
Patients who have an active infection that requires treatment.
Patients who have a history of certain heart problems.
Patients who have a history of certain liver problems.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Alexandra Hospital	Athens	Greece
Aaorczw Upfto Sbjfhgaph Lesygc Do Btxetvg	Bologna	Italy

Trial status

Country	Status	Recruitment Start
France	Not recruiting	08.09.2014
Greece	Not recruiting	08.09.2014
Italy	Not recruiting	08.09.2014

Trial locations

Investigated drugs:

Acalabrutinib

Acalabrutinib is a medication being studied for its effectiveness in treating Waldenström Macroglobulinemia, a type of blood cancer. It works by blocking a specific protein in the body that helps cancer cells grow. This study aims to see how well acalabrutinib can help reduce the cancer in patients with this condition.

Investigated diseases:

Waldenström Macroglobulinemia – This is a rare type of non-Hodgkin lymphoma characterized by an overproduction of abnormal white blood cells called lymphoplasmacytic cells. These cells accumulate in the bone marrow, lymph nodes, and spleen, leading to various symptoms. As the disease progresses, it can cause anemia, fatigue, and bleeding due to the crowding out of normal blood cells. Patients may also experience hyperviscosity syndrome, where the blood becomes too thick, leading to vision problems, headaches, and dizziness. The disease is typically slow-growing, and symptoms can vary widely among individuals.

Trial ID:

2023-509356-34-00

Protocol code:

ACE-WM-001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Acalabrutinib for Patients with Waldenström Macroglobulinemia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?