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Study on Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma Not Eligible for Transplant

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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 Follicular Lymphoma, which is a slow-growing form of non-Hodgkin lymphoma. The study is investigating the effectiveness and safety of a treatment combination using two medications: Rituximab and Lenalidomide. Rituximab is a monoclonal antibody, which is a type of protein designed to target and destroy specific cells, while Lenalidomide is an immunosuppressor that helps to modify the immune system's response. The trial compares the combination of these two drugs, known as R2, with the use of Rituximab alone, following initial treatment with Rituximab and chemotherapy.

The purpose of the study is to see if the combination of Rituximab and Lenalidomide can improve the time patients live without the disease getting worse, known as progression-free survival. Participants in the study will receive either the combination treatment or Rituximab alone as maintenance therapy after their initial treatment. The study will last for up to 24 months, during which participants will be monitored regularly to assess the effectiveness and any side effects of the treatments.

This trial is designed for patients with Follicular Lymphoma who have experienced a return or worsening of their disease after previous treatments and are not eligible for a type of intensive treatment called autologous stem cell transplantation. The study aims to provide valuable information on whether the combination of Rituximab and Lenalidomide offers better outcomes compared to Rituximab alone, potentially leading to improved treatment options for patients with this condition.

The research process

The trial runs in 6 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 verifying the diagnosis of follicular lymphoma and ensuring compliance with specific health criteria such as blood counts and organ function.
A re-biopsy may be required if there is a suspicion of disease transformation.
Step 2
Randomization
Participants are randomly assigned to one of two groups: one receiving a combination of rituximab and lenalidomide (R2), and the other receiving rituximab alone.
This process ensures that each participant has an equal chance of being placed in either group.
Step 3
Treatment phase
Participants in the R2 group receive rituximab and lenalidomide. Rituximab is administered either intravenously or subcutaneously, while lenalidomide is taken orally.
The dosage and frequency of administration are determined by the study protocol and are monitored by the study team.
Step 4
Maintenance phase
After the initial treatment, participants enter a maintenance phase where the assigned treatment continues to prevent disease progression.
The duration of this phase is determined by the study protocol and may last several months.
Step 5
Monitoring and follow-up
Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects.
Participants undergo periodic evaluations, including blood tests and imaging studies, to track the progress of the disease.
Step 6
End of study
The study concludes with a final assessment to evaluate the overall outcomes of the treatment.
Participants are informed of the results and any further steps that may be necessary for their health management.

Who can join the trial?

16 criteria

Have **follicular lymphoma** grade I, II, or IIIa. This is a type of cancer that affects the lymphatic system.
Be willing and able to follow the study rules for the entire duration.
Have a certain level of **neutrophils** (a type of white blood cell) and **platelets** (cells that help with blood clotting) unless affected by the lymphoma.
Have a **creatinine clearance** of at least 40 ml/min. This is a measure of how well the kidneys are working.
Agree to use effective **contraception** during the study. This means using methods to prevent pregnancy.
Females who can have children must have a negative pregnancy test before starting the study and agree to regular pregnancy tests during and after the study.
Male participants must agree to use a condom during sexual contact with females who can have children, even if they have had a vasectomy, and not donate semen during and after the study.
Understand that the study drug may have risks for unborn babies and agree not to donate blood during and after the study.
Have had a first or second relapse or progression after previous treatment with R-chemotherapy.
Previous treatment with Bendamustine is allowed if the relapse happened 24 months or more after treatment.
Be over 18 years old.
Not be eligible for high-dose chemotherapy and **ASCT** (a type of stem cell transplant) due to age (65 or older), poor health, or other serious health issues.
Have stage II, III, or IV lymphoma at relapse, according to the Ann Arbor classification.
Need treatment based on specific guidelines for follicular lymphoma, such as having systemic symptoms, a high tumor burden, or other serious conditions.
Be able to attend study visits and follow other study requirements.
Have an **ECOG performance status** of 2 or less, which measures the ability to perform daily activities, unless affected by lymphoma.

Who cannot join the trial?

4 criteria

Patients who have not responded to initial treatment for **follicular lymphoma** cannot participate. **Follicular lymphoma** is a type of cancer that affects the lymphatic system.
Patients who are not within the specified age range for the study are excluded. The study is open to certain age groups only.
Patients who belong to a vulnerable population are not eligible. A vulnerable population includes groups that may have a higher risk of harm or exploitation.
Patients who do not meet the specific health criteria set by the study are excluded. These criteria ensure the safety and effectiveness of the study for participants.

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Verified sites

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

Azienda Ospedaliero Universitaria Di Sassari
Responsive
Sassari, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy

Trial locations

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Investigated drugs

Rituximab
is a medication used to treat certain types of cancer, including follicular lymphoma. It works by targeting specific proteins on the surface of cancer cells, helping the immune system to destroy them. In this trial, Rituximab is used both in combination with other treatments and on its own to help maintain remission after initial therapy.
Lenalidomide
is a medication that helps the immune system fight cancer. It is used in this trial in combination with Rituximab to see if it can improve the time patients remain free from cancer progression. Lenalidomide works by affecting the immune system and has anti-cancer properties, making it a potential option for maintenance therapy in patients with relapsed or refractory follicular lymphoma.

Rituximab

What is already known about the treatment

Rituximab
Rituximab is administered intravenously, meaning it is given through a vein. It is currently well-established in medical literature and widely used in clinical practice. The main therapeutic indication for Rituximab is the treatment of certain types of lymphoma, including follicular lymphoma. It works by targeting a specific protein called CD20 found on the surface of B-cells, leading to the destruction of these cells. Rituximab is classified as a monoclonal antibody.
Lenalidomide
Lenalidomide is taken orally in the form of a capsule. It is recognized in medical literature and used in various treatment protocols. The primary therapeutic use of Lenalidomide is for certain blood cancers, including follicular lymphoma. It functions by modulating the immune system and inhibiting the growth of cancer cells. Lenalidomide is classified as an immunomodulatory drug.

Investigated diseases

Follicular lymphoma – Follicular lymphoma is a type of non-Hodgkin lymphoma that typically arises from B-lymphocytes, a kind of white blood cell. It is characterized by slow growth and often presents with painless swelling of lymph nodes. The disease can spread to other parts of the body, including the bone marrow and spleen. Patients may experience symptoms such as fatigue, night sweats, and weight loss. Follicular lymphoma is known for its indolent nature, meaning it progresses slowly over time. Despite its slow progression, it can transform into a more aggressive form of lymphoma in some cases.