Not recruiting

Study on Ibrutinib, CD20 Ab and Venetoclax for Patients with Untreated Mantle Cell Lymphoma

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on a type of cancer called mantle cell lymphoma, which is a form of non-Hodgkin lymphoma. This cancer affects the lymphatic system, a part of the body's immune system. The trial investigates how well combination drug therapies work for patients who have not yet received treatment for this disease. The study involves several drugs: Ibrutinib, Venetoclax, Rituximab, and Obinutuzumab. Ibrutinib and Venetoclax are taken orally, which means in pill form, while Rituximab and Obinutuzumab are given as an infusion, entering the body through a vein.

The main goal of the study is to determine the effectiveness of these combination therapies in reducing or eliminating signs of cancer in the blood and bone marrow. This is measured using a technique called droplet digital polymerase chain reaction (ddPCR), which helps detect very small amounts of cancer cells. The study looks specifically at the "minimum residual disease" rate, which means the amount of cancer cells that remain after treatment.

Participants in the study will receive either a combination of Ibrutinib plus a CD20 antibody, such as Rituximab or Obinutuzumab, or a combination of Ibrutinib, Venetoclax, and a CD20 antibody. These treatments are given over six cycles, and researchers will monitor how the cancer responds to these therapies. Some participants may receive a placebo. This trial aims to find the most effective treatment options for reducing cancer in patients with untreated mantle cell lymphoma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
Blood tests and imaging studies may be performed to assess the stage of the mantle cell lymphoma.
Step 2
Treatment cycle 1-6
The treatment involves a combination of medications administered over six cycles.
The medications include ibrutinib taken orally, venetoclax taken orally, and rituximab administered via injection or intravenous infusion.
Each cycle lasts approximately 28 days, during which the medications are taken according to a specific schedule provided by the healthcare team.
Step 3
Monitoring and evaluation
Throughout the treatment cycles, regular monitoring is conducted to evaluate the response to the medications.
This includes blood tests and possibly imaging studies to assess the reduction of lymphoma cells.
Step 4
End of induction assessment
At the end of the six treatment cycles, an assessment is performed to determine the level of minimum residual disease (MRD) using a technique called droplet digital PCR (ddPCR).
This assessment helps to evaluate the effectiveness of the treatment in reducing the lymphoma cells.
Step 5
Follow-up
After the treatment cycles, follow-up visits are scheduled to monitor the patient's health and any long-term effects of the treatment.
These visits may include additional blood tests and imaging studies to ensure the lymphoma remains under control.

Who can join the trial?

13 criteria

Patient must be between 18 and 79 years old at the time of signing the informed consent form.
Patient must have stage II-IV disease, which means the disease is advanced and can be measured with at least one lymph node larger than 1.5 cm, and the patient needs treatment according to the doctor.
Patient must have an ECOG performance status of 0 to 2, which is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, while 2 means the patient is up and about more than half of waking hours.
Patient must have a life expectancy of more than 3 months.
For patients in France, they must be affiliated with any social security system.
Patient must have understood and voluntarily signed and dated an informed consent form before any study-specific assessments or procedures are conducted.
Patient must be willing and able to follow the study visit schedule and other study requirements.
Women who can have children must have a negative pregnancy test before starting the study treatment and agree not to breastfeed during the study and for at least 18 months after the last drug administration.
Men or women who can have children must agree to use a highly effective method of birth control (with a failure rate of less than 1%) during treatment and for eighteen months after the last drug administration.
Patient must have a confirmed diagnosis of mantle cell lymphoma, which is a type of cancer, according to the WHO classification. This diagnosis must be confirmed by specific tests showing certain markers like CD5, CD20, and cyclin D1, or a specific genetic change called the t(11;14) translocation.
Patient must not have received any treatment for mantle cell lymphoma before.
Patient must have adequate kidney function, shown by a creatinine clearance greater than 50 mL/min, which is a measure of how well the kidneys are working.
Patient must have adequate liver function according to local laboratory standards, with specific levels for liver enzymes (AST and ALT) and bilirubin, unless the bilirubin increase is due to a condition called Gilbert's syndrome or is not related to the liver.

Who cannot join the trial?

4 criteria

Patients who have already received treatment for mantle cell lymphoma cannot participate. Mantle cell lymphoma is a type of cancer that affects the lymph nodes.
Individuals who are not within the specified age range for the study are excluded. The study is open to certain age groups only.
Participants who are part of a vulnerable population, meaning those who might need special protection or care, are not eligible.
Both men and women can participate, but those who do not meet other specific criteria will be excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Az St-Jan Brugge-Oostende A.V.
Verified
Brugge, Belgium
Besancon University Hospital Center
Verified
Besançon, France
CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Ibrutinib
is a medication used in this trial to treat patients with mantle cell lymphoma. It works by blocking a specific protein that helps cancer cells grow and survive, thereby slowing down or stopping the progression of the disease.
CD20 Antibody
is a type of therapy that targets a protein found on the surface of certain cancer cells, including those in mantle cell lymphoma. By binding to this protein, the antibody helps the immune system recognize and destroy the cancer cells.
Venetoclax
is another medication used in the trial, which helps to treat mantle cell lymphoma by targeting a protein that prevents cancer cells from dying. By inhibiting this protein, Venetoclax promotes the natural death of cancer cells, aiding in the reduction of the disease.

What is already known about the treatment

Ibrutinib
Ibrutinib is administered orally in the form of capsules or tablets. It is currently well-established in medical literature as a treatment for certain types of blood cancers, including mantle cell lymphoma. The main therapeutic indication for Ibrutinib is to treat patients with untreated mantle cell lymphoma. It works by inhibiting a protein called Bruton's tyrosine kinase (BTK), which is involved in the growth and survival of cancer cells. Ibrutinib is classified as a targeted therapy, specifically a BTK inhibitor.
Venetoclax
Venetoclax is taken orally in tablet form. It is recognized in medical literature for its role in treating certain blood cancers, such as chronic lymphocytic leukemia and mantle cell lymphoma. The primary therapeutic use of Venetoclax in this trial is for patients with untreated mantle cell lymphoma. It functions by inhibiting the B-cell lymphoma 2 (BCL-2) protein, which helps cancer cells survive, thereby promoting their death. Venetoclax is classified as a BCL-2 inhibitor, a type of targeted cancer therapy.

Investigated diseases

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 bone marrow and spleen. 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 can spread to other parts of the body, including the gastrointestinal tract and bone marrow. Symptoms may include fatigue, fever, night sweats, and weight loss. The progression of mantle cell lymphoma can vary, with some cases advancing more rapidly than others.