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Study on the Effectiveness and Safety of Pirtobrutinib and Rituximab for Untreated Adult Patients with Indolent Mantle Cell Lymphoma

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What is this trial about?

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

This clinical trial is focused on studying a type of cancer called Mantle Cell Lymphoma (MCL), which is a form of non-Hodgkin's lymphoma. The study is specifically looking at patients with a less aggressive form of this disease, known as indolent MCL, who have not yet received any treatment. The trial will test the effectiveness and safety of a new treatment combination using two medications: pirtobrutinib and rituximab. Pirtobrutinib, also known by its code names LOXO-305 and LY3527727, is taken orally in the form of film-coated tablets. Rituximab is given as an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to see if this combination of pirtobrutinib and rituximab can be a good alternative to the usual treatments for MCL, which often involve a mix of chemotherapy and immunotherapy. The study will follow participants over a period of time to monitor how well the treatment works and to check for any side effects. Participants will receive the treatment and be observed for changes in their condition, with regular assessments to track their progress. The study aims to provide valuable information on whether this new combination can help manage the disease more effectively than current standard treatments.

Throughout the study, researchers will collect data on how the treatment affects the cancer and the overall health of the participants. This includes looking at the rate of complete remission, which means the cancer is no longer detectable, and monitoring any adverse effects that may occur. The study will also evaluate the quality of life of participants using questionnaires designed to measure well-being and daily functioning. By the end of the study, the goal is to have a clearer understanding of the potential benefits and risks of using pirtobrutinib and rituximab together for treating indolent MCL.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be required to provide written informed consent. This consent confirms understanding and agreement to comply with the study's requirements and restrictions.
Step 2
Initial assessments
Initial assessments will be conducted to confirm eligibility. These assessments include a review of medical history, physical examination, and laboratory tests to ensure the patient meets the study criteria.
Step 3
Treatment initiation
The treatment involves a combination of two medications: pirtobrutinib and rituximab. Pirtobrutinib is administered orally in the form of Jaypirca 100 mg film-coated tablets. The dosage and frequency will be determined by the study protocol.
Rituximab is administered through an intravenous infusion. The specific dosage and schedule will be provided by the healthcare team.
Step 4
Treatment cycles
The treatment is organized into cycles. Each cycle includes the administration of the medications as per the study protocol. The primary objective is to assess the complete remission rate by the end of Cycle 6.
Step 5
Monitoring and assessments
Throughout the study, regular monitoring and assessments will be conducted. These include evaluating the effectiveness of the treatment and monitoring for any adverse events. The patient's quality of life will also be assessed using specific questionnaires.
Step 6
End of treatment
At the end of the treatment period, a final assessment will be conducted to evaluate the overall response to the treatment. This includes a review of the patient's health status and any changes in the condition.
Step 7
Follow-up
After completing the treatment, follow-up visits will be scheduled to monitor the patient's long-term health and any potential late effects of the treatment.

Who can join the trial?

19 criteria

Must be an adult (18 years or older).
Must have a stable disease without signs of getting worse for at least 3 months.
Women who can have children must have a negative pregnancy test and agree to use very effective birth control during the study and for a certain time after.
Men must use very effective birth control if they are sexually active with a woman who can have children, during the study and for a certain time after.
Must be willing and able to sign a consent form agreeing to follow the study rules.
Cannot be part of another clinical trial or have taken an experimental drug for a different condition in the past 2 years.
Must have a confirmed diagnosis of Mantle Cell Lymphoma (MCL) according to specific medical classifications.
Must not have received any prior treatment for MCL, except for a diagnostic procedure called splenectomy.
Must not have symptoms related to MCL.
Must have an ECOG performance status of less than 2, which means being fully active or having some symptoms but still able to carry out light work.
Must be in clinical stage I-IV according to the Ann Arbor classification without symptoms caused by MCL.
Patients with a type of MCL that mainly affects the bone marrow or blood are eligible, as long as they have a low tumor burden.
Must meet certain laboratory test values at screening, including:
- Neutrophil count of at least 1x10⁹/L
- Hemoglobin level of at least 100 g/L
- Platelet count of at least 100x10⁹/L
- Liver enzymes (AST and ALT) not more than 3 times the upper limit of normal (ULN)
- Total bilirubin not more than 1.5 times ULN, unless due to a condition called Gilbert’s disease
- Creatinine clearance of at least 30 ml/min, which measures kidney function
- Normal blood clotting ability, with specific test values not greater than 1.5 times ULN

Who cannot join the trial?

3 criteria

Patients who have already received treatment for their condition cannot participate.
Patients with a type of MCL that is not considered indolent (a slow-growing form of the disease) are not eligible.
Patients who are part of a vulnerable population (groups that may need special protection or care) are not eligible.

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Verified sites

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

Hestia Duran I Reynals
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L'hospitalet De Llobregat, Spain
Hospital Clinic De Barcelona
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Barcelona, Spain
Hospital Costa del Sol
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Marbella, Spain

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Investigated drugs

Pirtobrutinib
is a medication being studied for its potential to help treat a type of cancer called Mantle Cell Lymphoma, which is a slow-growing form of cancer that affects the lymph nodes. This medication works by blocking certain proteins in the body that help cancer cells grow and survive. By stopping these proteins, pirtobrutinib may help to slow down or stop the growth of cancer cells.
Rituximab
is a medication that is used to treat certain types of cancer, including Mantle Cell Lymphoma. It is a type of therapy known as a monoclonal antibody, which means it is designed to target and attach to specific proteins on the surface of cancer cells. By doing this, rituximab helps the body's immune system to recognize and destroy these cancer cells. In this trial, rituximab is being used in combination with pirtobrutinib to see if the two medications together can be more effective in treating the cancer than other standard treatments.

What is already known about the treatment

Pirtobrutinib – Pirtobrutinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating indolent forms of Mantle Cell Lymphoma (MCL) in adults who have not received prior treatment. It is being evaluated in combination with rituximab as a potential alternative to traditional immunochemotherapy. Pirtobrutinib works by targeting specific proteins in cancer cells, disrupting their growth and survival. It is classified as a Bruton's tyrosine kinase (BTK) inhibitor, which helps to slow down or stop the progression of cancer.

Investigated diseases

Mantle Cell Lymphoma – Mantle Cell Lymphoma (MCL) is a type of non-Hodgkin lymphoma that originates from B-cells, a type of white blood cell. It is characterized by the overproduction of abnormal B-cells that accumulate in the lymph nodes, spleen, bone marrow, and sometimes the gastrointestinal tract. The disease typically progresses slowly, but it can become more aggressive over time. Patients may experience symptoms such as swollen lymph nodes, fatigue, fever, night sweats, and weight loss. As the disease advances, it can lead to complications due to the impaired function of affected organs. MCL is considered indolent when it progresses at a slower rate and may not immediately require aggressive treatment.