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Study of Acalabrutinib, Venetoclax, and Rituximab for Patients with Newly Diagnosed Mantle Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Mantle Cell Lymphoma, which is a rare form of non-Hodgkin’s lymphoma. The study is specifically for patients who have not received any previous treatment for this condition. The trial will test the effectiveness of a combination of three medications: Acalabrutinib, Venetoclax, and Rituximab. Acalabrutinib and Venetoclax are taken as tablets, while Rituximab is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well this combination of medications works in treating Mantle Cell Lymphoma. Participants in the study will receive these medications over a period of time, and their health will be monitored closely by the research team. The study will involve several cycles of treatment, and the participants will have regular check-ups to assess their response to the treatment. The goal is to see if the combination can help achieve a state where no cancer cells are detectable, known as MRD-negative complete response.

Throughout the study, participants will be observed for any side effects or changes in their condition. The research team will collect data on how the disease responds to the treatment and how long the response lasts. This information will help determine the potential benefits and risks of using Acalabrutinib, Venetoclax, and Rituximab together for treating Mantle Cell Lymphoma. The study aims to provide valuable insights into improving treatment options for patients with this type of cancer.

1 joining the study

Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.

You will undergo initial assessments to confirm eligibility, including medical history review and physical examination.

2 treatment initiation

The treatment phase begins with the administration of medications. You will take acalabrutinib 100 mg tablets orally. The frequency and duration will be specified by the study team.

You will also take venetoclax tablets, starting with a lower dose and gradually increasing as directed by the study team. The specific dosage and schedule will be provided to you.

3 rituximab administration

You will receive rituximab through an infusion. The schedule for these infusions will be communicated to you by the study team.

Infusions will be conducted in a clinical setting under the supervision of healthcare professionals.

4 monitoring and assessments

Throughout the study, regular monitoring and assessments will be conducted to evaluate your response to the treatment.

These assessments may include blood tests, imaging studies, and other evaluations as necessary.

5 completion of treatment cycle

The treatment cycle will continue for a specified duration, typically until the completion of Cycle 13.

At the end of the treatment cycle, further assessments will be conducted to determine the efficacy of the treatment.

6 follow-up

After completing the treatment cycle, follow-up visits will be scheduled to monitor your health and any long-term effects of the treatment.

These visits will help ensure your well-being and gather additional data for the study.

Who Can Join the Study?

  • Participant must be at least 18 years old or the legal age of consent in their area, whichever is older, at the time of signing the consent form.
  • Participant must have a confirmed diagnosis of Mantle Cell Lymphoma (MCL), a type of blood cancer, based on specific medical criteria.
  • Participant must be in Clinical Stage II, III, or IV of the disease, which means the disease has progressed to a certain extent and requires treatment.
  • Participant must have at least one measurable site of disease, which means a tumor or affected area that can be measured using medical imaging like a CT or MRI scan. Alternatively, if the disease is present in the blood and not in the lymph nodes, the participant must have an enlarged spleen and bone marrow involvement.
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2, which indicates how well they can perform daily activities. A status of 3 is acceptable if it is due to lymphoma.
  • Participant must have available tumor samples for genetic testing, which helps in understanding the disease better. If the disease is present in the blood and not in the lymph nodes, bone marrow samples may be used instead.
  • Participant must have adequate organ and bone marrow function, meaning their organs and bone marrow are working well enough to participate in the study.
  • Participants must agree to use contraception to prevent pregnancy during the study and for a specified time after the study drugs are stopped. This applies to both male and female participants.
  • Participant must be able to give informed consent, which means they understand the study and agree to follow its requirements.

Who Cannot Join the Study?

  • Patients who have received any previous treatment for Mantle Cell Lymphoma cannot participate. This means if you have already been treated for this condition, you are not eligible.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to follow the study procedures or comply with the study requirements cannot participate.
  • Patients with other medical conditions that might interfere with the study results cannot participate. This means if you have other health issues that could affect the study, you may not be eligible.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the child.
  • Patients who are part of a vulnerable population, such as those who cannot give informed consent, cannot participate. This means if you are unable to understand the study and agree to participate, you are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Universidade De Santiago De Compostela Santiago De Compostela Spain
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Pratia S.A. Skorzewo Poland
Hospital Universitario 12 De Octubre Madrid Spain
Snjgvbmh Pcyuoouhf Siu z ogwx Gdynia Poland
Hvpkhzmn Vopf dmmdgtot Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
28.09.2023
Spain Spain
Not recruiting
28.09.2023

Trial locations

Investigated drugs:

Acalabrutinib is a medication used in this clinical trial to help treat mantle cell lymphoma, a type of cancer. It works by blocking a specific protein in the body that helps cancer cells grow. By stopping this protein, acalabrutinib can help slow down or stop the growth of cancer cells.

Venetoclax is another medication in the trial that helps treat mantle cell lymphoma. It works by targeting and blocking a protein that prevents cancer cells from dying. By blocking this protein, venetoclax helps to kill the cancer cells and reduce the size of the tumor.

Rituximab is a therapy used in the trial that helps the immune system find and destroy cancer cells. It is a type of antibody that attaches to a specific protein on the surface of cancer cells. Once attached, it helps the body’s immune system recognize and attack the cancer cells, helping to reduce the number of cancer cells in the body.

Investigated diseases:

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a type of non-Hodgkin’s lymphoma, which is a cancer that originates in the lymphatic system. It specifically affects B-cells, a type of white blood cell that plays a crucial role in the immune response. The disease typically begins in the outer edge of a lymph node called the mantle zone. As it progresses, it can spread to other lymph nodes, bone marrow, and sometimes the spleen and gastrointestinal tract. The progression of Mantle Cell Lymphoma can vary, with some cases advancing slowly while others may progress more rapidly. Symptoms often include swollen lymph nodes, fever, night sweats, and unexplained weight loss.

Trial ID:
2023-505205-16-00
Protocol code:
D822GC00001
NCT ID:
NCT05951959
Trial Phase:
Therapeutic exploratory (Phase II)

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