Study of Acalabrutinib and Rituximab for Elderly Patients with Untreated Mantle Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying Mantle Cell Lymphoma (MCL), a type of cancer that affects the lymphatic system, which is part of the body’s immune system. The study involves two treatments: Acalabrutinib, also known by its code name ACP-196, and Rituximab. Acalabrutinib is a type of medication called a BTK inhibitor, which works by blocking a protein that helps cancer cells grow. Rituximab is a medication that targets specific cells in the immune system to help fight cancer.

The purpose of this study is to evaluate how well the combination of acalabrutinib and rituximab works in elderly patients who have not yet received treatment for their mantle cell lymphoma. Participants in the study will receive these medications and will be monitored over time to see how their disease responds. The study will compare the results to previous data from another trial to understand the effectiveness of this treatment combination.

Throughout the study, participants will be regularly assessed to track their progression-free survival, which means the length of time during and after treatment that the patient lives with the disease without it getting worse. Other aspects such as the complete response rate, overall survival, and safety of the treatment will also be evaluated. The study aims to provide valuable insights into the treatment of mantle cell lymphoma in elderly patients.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and specific health criteria related to mantle cell lymphoma (MCL).

Eligibility criteria include being 60 years or older, having untreated MCL, and meeting certain health standards such as blood counts and kidney function.

2 treatment initiation

The treatment phase begins with the administration of acalabrutinib and rituximab. Acalabrutinib is taken orally, and the dosage and frequency are determined by the study protocol.

Rituximab is administered according to a schedule that will be explained during the treatment phase. The duration of this treatment is based on the study’s objectives and individual response.

3 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment. This includes imaging tests and blood work to measure the effectiveness and safety of the medications.

The primary goal is to evaluate progression-free survival, which is the time during and after treatment that the patient lives without the disease worsening.

4 evaluation of response

At 6 months, a complete response rate is evaluated. This involves determining the extent of disease reduction or remission.

Additional assessments include molecular remission rate and overall response rate, which help in understanding the treatment’s impact on the disease.

5 long-term follow-up

Long-term follow-up is conducted to monitor overall survival and the duration of response. This includes periodic check-ups and tests to ensure continued health and to detect any signs of disease progression.

Safety assessments are also part of this phase, focusing on any adverse effects experienced during the trial.

Who Can Join the Study?

Must be at least 60 years old.
If a woman can have children and is sexually active, she must use very effective birth control methods during treatment and for a certain time after the last dose of the study drugs.
Must have a confirmed diagnosis of Mantle Cell Lymphoma (MCL), which is a type of cancer, with specific cell characteristics.
The cancer must be at Stage II-IV, which means it is measurable by scans and needs treatment according to the doctor.
Must not have had any previous treatment for MCL, except for localized radiation or a short course of steroids to manage symptoms.
Must have an ECOG performance status of 0 to 2, which is a scale that measures how well a person can perform daily activities.
Must have a certain level of neutrophils (a type of white blood cell) and platelets (cells that help with blood clotting), unless these levels are low due to the lymphoma.
Must have a creatinine clearance greater than 30 ml/min, which is a measure of kidney function.
Must have AST and/or ALT (liver enzymes) less than 3 times the upper limit of normal, and P-bilirubin (a liver function marker) less than 3 times the upper limit of normal.
Must be able to provide written consent voluntarily, meaning they agree to participate in the study after understanding all the details.

Who Cannot Join the Study?

Patients who have already received treatment for Mantle Cell Lymphoma (MCL) cannot participate. This means if you have been treated for this type of cancer before, you are not eligible.
Patients who are part of a vulnerable population are not eligible. A vulnerable population includes groups who might be at higher risk of harm or exploitation, such as children or people with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Region Vaesterbotten	Umea	Sweden
St. Olavs Hospital HF	Trondheim	Norway
Helse Stavanger HF	Stavanger	Norway
Oulu University Hospital	Oulu	Finland
NU Hospital Group-Vaestra Goetalandsregionen	Trollhattan	Sweden
Lund University Hospital	Lund	Sweden
Laenssjukhuset I Kalmar Region Kalmar Laen	Kalmar	Sweden
Region Norrbotten	Lulea	Sweden
Odense University Hospital	Odense	Denmark
Karolinska University Hospital	Solna	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Region Halland	Varberg	Sweden
Region Sjaelland	Holbæk	Denmark
Uadlwxz Uclmpskfqf Hbujefcp	Uppsala	Sweden
Htnip Bdbhtn Hk	Bergen	Norway
Hsqjgfwz Uigqqgdfnr Cjwckdy Hnjxuruw	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	07.12.2021
Finland	Not recruiting	07.12.2021
Norway	Not recruiting	07.12.2021
Sweden	Not recruiting	07.12.2021

Trial locations

Investigated drugs:

Acalabrutinib

Acalabrutinib is a medication used in this trial to treat patients with mantle cell lymphoma. It works by blocking a specific protein in the body that helps cancer cells grow and survive. This medication is being tested to see if it can help stop the progression of the disease in elderly patients who have not received any previous treatment.

Rituximab is another medication used in the trial, often given in combination with other cancer treatments. It is a type of therapy that targets specific cells in the immune system, helping to destroy cancer cells. In this study, it is being used alongside acalabrutinib to evaluate its effectiveness in improving the outcomes for patients with untreated mantle cell lymphoma.

Investigated diseases:

Mantle cell lymphoma

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, which are a type of white blood cell. It typically begins in the outer edge of a lymph node, known as the mantle zone. The disease often progresses by spreading to other lymph nodes, bone marrow, and sometimes the spleen or gastrointestinal tract. Patients may experience symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The progression of Mantle Cell Lymphoma can vary, with some cases advancing more rapidly than others.

Trial ID:

2023-509864-96-00

Protocol code:

NLG-MCL8

NCT ID:

NCT05214183

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Acalabrutinib and Rituximab for Elderly Patients with Untreated Mantle Cell Lymphoma

What is this study about?

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