Study on Rituximab, Bendamustine, Cytarabine, and Venetoclax for High-Risk Elderly Patients with 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 (MCL), which is a rare form of non-Hodgkin’s lymphoma. The study is specifically for high-risk elderly patients who have not received treatment before. The treatment being tested involves a combination of medications: Rituximab, Bendamustine, and Cytarabine, followed by Venetoclax. Rituximab is a monoclonal antibody, Bendamustine is an alkylating agent, Cytarabine is a pyrimidine analogue, and Venetoclax is a BCL2 inhibitor. These medications are used to target and kill cancer cells in different ways.

The purpose of the study is to see if adding Venetoclax after the initial treatment with Rituximab, Bendamustine, and Cytarabine can improve the outcomes for patients. The study will follow participants over a period to monitor their response to the treatment. Initially, patients will receive Rituximab, Bendamustine, and Cytarabine through intravenous infusions, which means the medication is given directly into a vein. After this phase, Venetoclax will be taken orally, which means it is swallowed in pill form. The study aims to determine if this combination can help patients live longer without the disease getting worse.

Throughout the study, researchers will observe how well the treatment works and how safe it is for the participants. They will look at how long patients remain free from disease progression, the overall survival rates, and any side effects that may occur. The study will also assess the proportion of patients who achieve complete remission, which means the disappearance of all signs of cancer in response to treatment. This trial is an important step in finding more effective treatments for high-risk elderly patients with Mantle Cell Lymphoma.

1 initial treatment phase

The treatment begins with the administration of rituximab, bendamustine, and cytarabine. These medications are given through a vein, a method known as intravenous administration.

This phase is designed to target and reduce the lymphoma cells in the body. The specific schedule and dosage will be determined by the healthcare provider based on individual health conditions and response to treatment.

2 venetoclax administration

Following the initial treatment phase, venetoclax is introduced. This medication is taken orally, meaning it is swallowed in the form of a pill.

The purpose of venetoclax is to further improve treatment outcomes by targeting specific cancer cells. The dosage and duration will be tailored to the patient’s needs and monitored by the healthcare team.

3 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects. This includes blood tests, imaging studies, and other necessary evaluations.

The healthcare team will provide guidance on managing any side effects and will adjust the treatment plan as needed to ensure the best possible outcomes.

4 completion and evaluation

Upon completion of the treatment schedule, a comprehensive evaluation is performed to determine the overall response to the therapy.

This includes assessing the progression-free survival, which measures the length of time during and after treatment that the patient lives with the disease without it getting worse.

Who Can Join the Study?

Patients who have not been treated before for Mantle Cell Lymphoma (MCL) and are 65 years or older, if they are considered FIT based on a special health assessment for older adults.
Patients 64 years or younger who are not suitable for high-dose chemotherapy and transplantation, as decided by their doctor. This decision is based on a health rating scale called the Cumulative Illness Rating Scale (CIRS).
Patients must have a measurable disease with a size of at least 1.5 cm in the longest direction and measurable in two directions.
Patients must have an ECOG performance status of 2 or less. This is a scale that measures how well a patient can perform daily activities.
Patients must test positive for cyclin D1 and/or SOX11. If cyclin D1 is negative, SOX11 must be positive.
Patients must have adequate kidney function, with a creatinine clearance greater than 50 mL/min and normal urine output.
Patients must have adequate liver function, with specific liver enzyme levels and bilirubin within acceptable limits, unless these are affected by the tumor or inherited conditions.
Patients who have a positive test for Hepatitis B core antibody (HBcAb) but are negative for other hepatitis B markers can join if they receive proper antiviral treatment at least two weeks before starting the study treatment.
Patients must provide written informed consent, which means they agree to participate in the study after understanding all the details.

Who Cannot Join the Study?

Patients with other types of cancer besides Mantle Cell Lymphoma cannot participate. Mantle Cell Lymphoma is a type of cancer that affects the lymph nodes.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
Patients who are not considered high-risk (HR) for Mantle Cell Lymphoma cannot participate. High-risk patients are those who have a greater chance of the disease progressing or returning.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups who may have difficulty giving informed consent or are at higher risk of harm.
Patients who have not received the standard treatment known as R-BAC cannot participate. R-BAC is a combination of drugs used to treat Mantle Cell Lymphoma.
Patients who are unable to take the additional drug called venetoclax cannot participate. Venetoclax is a medication that helps to kill cancer cells.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy

Other Sites

Site Name	City	Country
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Azienda Unita Sanitaria Locale Di Piacenza	Piacenza	Italy
Universita Cattolica Del Sacro Cuore	Rome	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Azienda Unita Locale Socio Sanitaria N 8 Berica	Vicenza	Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana	Treviso	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Pia Fondazione Di Culto E Religione Card G Panico	Tricase	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
ARNAS G. Brotzu	Cagliari	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Adxjbpy Oepemylechl Ogrhulfd Rbdhplm Vwaft Shpet Cpoitfbi	Palermo	Italy
Ixxetpig Rwyoiytky Pnc Lo Sbnnzb Dtb Tfhlmm Dvqb Ahgfvjr Iwxv Shvgue	Meldola	Italy
Algfmns Oqmnecacpsh Ukhvhwaivgswz Cgesvnecggts Dixtc Scwzlu E Dkxix Sidtxij Dp Tanbcp	Turin	Italy
Aqbypzj Okwugpbcogt Nizlgvsir Sv Aluvrds E Badtsy E C Apchya Aiczkynztuc	Alexandria	Italy
Asmmzhw Uds Ifoee Di Rgqufz Eppwtd	Reggio Emilia	Italy
Ahphmnf Uomhn Sdhvgbffh Lnzbud Dg Bcvqasv	Bologna	Italy
Uyyppqnzqt Derez Sbfdn Dx Regt Ls Szxxqokq	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	03.09.2018

Trial locations

Investigated drugs:

Rituximab is a medication used to treat certain types of cancer, including mantle cell lymphoma. It works by targeting specific proteins on the surface of cancer cells, helping the immune system to destroy them.

Bendamustine is a chemotherapy drug that is used to treat cancer by damaging the DNA of cancer cells, which prevents them from dividing and growing.

Cytarabine is another chemotherapy medication that interferes with the DNA of cancer cells, stopping them from multiplying and spreading.

Venetoclax is a medication that helps to kill cancer cells by blocking a protein that allows them to survive. It is used in this trial to see if it can improve the effectiveness of the standard treatment for 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 lymph nodes but can also affect other areas such as the spleen, bone marrow, and digestive tract. The disease is characterized by the overproduction of abnormal B-cells, which can lead to the enlargement of lymph nodes and other organs. As the disease progresses, it may cause symptoms like fatigue, fever, night sweats, and weight loss. The progression of Mantle Cell Lymphoma can vary, with some cases advancing slowly while others may progress more rapidly.

Trial ID:

2024-511533-35-00

Protocol code:

FIL_V-RBAC

NCT ID:

NCT03567876

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Rituximab, Bendamustine, Cytarabine, and Venetoclax for High-Risk Elderly Patients with Mantle Cell Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?