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Study Comparing Shortened vs Standard Chemotherapy with Rituximab for Initial Treatment of High Tumor Burden Follicular Lymphoma in Newly Diagnosed Patients

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

This clinical trial is focused on studying the treatment of Follicular Lymphoma, a type of blood cancer that affects the lymphatic system. The study aims to compare two different treatment approaches for patients with a high tumor burden, which means a large amount of cancer in the body. The treatments being tested include a combination of chemotherapy and immunotherapy. Chemotherapy uses drugs to kill cancer cells, while immunotherapy helps the immune system fight cancer. The medications involved in this study are Rituximab, Doxorubicin, Vincristine, Prednisone, Obinutuzumab, Bendamustine, and Cyclophosphamide. Some patients will receive a standard number of chemotherapy cycles, while others will receive fewer cycles if they respond well to the treatment early on.

The purpose of the study is to determine if reducing the number of chemotherapy cycles in patients who respond early to treatment is as effective as the standard full-dose therapy in terms of how long patients live without the disease getting worse, known as progression-free survival. The study will involve regular visits to the clinic for treatment and monitoring. Patients will receive the medications through different methods, such as injections or oral tablets, depending on the specific drug. The study will also include a placebo group to compare the effects of the actual medications against no active treatment. The trial will last for several months, with follow-up visits to assess the effectiveness and safety of the treatments.

Throughout the study, patients will be closely monitored for any side effects and overall health. The trial will also evaluate other outcomes, such as overall survival, which is the length of time patients live after starting the treatment, and the quality of life, which refers to the general well-being of the patients during and after the treatment. The study aims to provide valuable information on the best treatment approach for patients with high tumor burden Follicular Lymphoma, potentially leading to improved treatment strategies in the future.

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 a review of medical history, physical examination, and necessary laboratory tests.
The assessment ensures that the patient meets the criteria for participation, such as having a diagnosis of follicular lymphoma and meeting specific health requirements.
Step 2
Treatment plan discussion
The treatment plan is explained, including the potential use of medications such as rituximab, doxorubicin, vincristine, prednisone, obinutuzumab, bendamustine, and cyclophosphamide.
The method of administration is discussed, which may include intravenous (IV) or oral routes, depending on the specific medication.
Step 3
Treatment initiation
Treatment begins with the administration of the prescribed medications. The frequency and dosage depend on the specific treatment regimen assigned.
Patients may receive medications intravenously or orally, with the schedule tailored to their individual treatment plan.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the patient's response to treatment. This includes physical exams, blood tests, and imaging studies as needed.
Follow-up visits are scheduled to ensure the treatment is effective and to manage any side effects that may occur.
Step 5
Treatment adjustment
Based on the patient's response, the treatment plan may be adjusted. This could involve changes in medication dosage or frequency.
The goal is to optimize the treatment's effectiveness while minimizing side effects.
Step 6
Completion of treatment
Upon completion of the treatment regimen, a final assessment is conducted to evaluate the overall response.
Patients may continue to be monitored for progression-free survival and overall health status.

Who can join the trial?

15 criteria

Must have a confirmed diagnosis of Follicular Lymphoma (a type of blood cancer).
Must have adequate liver function, which means a bilirubin level of 2 mg/dL or less, unless it is due to lymphoma or a condition called Gilbert syndrome.
Must have a Left Ventricular Ejection Fraction (LVEF) greater than 50% if receiving certain treatments. LVEF is a measure of how well the heart is pumping.
Must have a life expectancy of at least 6 months.
Must understand and voluntarily sign an informed consent form approved by the National Ethics Committee before starting any study procedures.
Must be able to follow the study visit schedule and other study requirements.
Women who can become pregnant and men must agree to use effective birth control if sexually active, from the time of signing the consent form until 12 months after the last dose of rituximab or 18 months after the last dose of obinutuzumab. Effective birth control methods include intrauterine devices, hormone-releasing systems, and sterilization procedures.
Must be 18 years of age or older.
Must have an ECOG performance status of 0-2, which is a scale used to assess how a disease affects a patient's daily living abilities.
Must not have received previous immunochemotherapy for lymphoma, although localized radiotherapy or up to 4 doses of rituximab are allowed.
Must have Ann Arbor stage II-IV disease, which indicates the extent of lymphoma spread in the body.
Must have a high tumor burden according to GELF criteria, which includes factors like large tumor size, involvement of multiple lymph nodes, or certain symptoms.
Must have at least one measurable site of nodal disease at baseline, which means a tumor size of at least 1.5 cm as seen on a CT scan or an active disease site on a PET scan.
Must have adequate blood counts, unless affected by lymphoma in the bone marrow. This includes a neutrophil count greater than 1.5 x 10⁹/L, a platelet count of at least 80 x 10⁹/L, and hemoglobin of at least 10 g/dL.
Must have adequate kidney function, which means a creatinine level of 2 mg/dL or less, unless it is due to lymphoma.

Who cannot join the trial?

8 criteria

Patients with any other type of cancer besides Follicular Lymphoma cannot participate.
Patients who have had previous treatment for Follicular Lymphoma are not eligible.
Patients with severe heart problems are excluded.
Patients with uncontrolled infections cannot join the study.
Pregnant or breastfeeding women are not allowed to participate.
Patients with a history of severe allergic reactions to the study medications are excluded.
Patients with other serious medical conditions that could interfere with the study are not eligible.
Patients who are unable to follow the study procedures are excluded.

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Verified sites

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

Azienda Ospedaliera Universitaria Senese
Responsive
Siena, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Azienda Ospedaliero Universitaria Di Sassari
Responsive
Sassari, Italy

Trial locations

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Investigated drugs

Chemotherapy
is a type of cancer treatment that uses drugs to destroy cancer cells. In this trial, chemotherapy is used to treat patients with Follicular Lymphoma, a type of blood cancer. The goal is to reduce the number of cancer cells in the body. Chemotherapy can be given in cycles, which means patients receive the treatment for a period, followed by a rest period. This trial is exploring whether fewer cycles of chemotherapy, when combined with immunotherapy, can be as effective as the standard number of cycles.
Immunotherapy
is a treatment that helps the body's immune system fight cancer. It works by boosting the natural defenses of the body to recognize and attack cancer cells. In this trial, immunotherapy is combined with chemotherapy to treat patients with Follicular Lymphoma. The aim is to see if this combination can effectively control the cancer while potentially allowing for a reduction in the number of chemotherapy cycles needed.

What is already known about the treatment

Immunotherapy – This medication is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. Currently, immunotherapy is a well-established treatment in medical literature, particularly for various types of cancer, including Follicular Lymphoma. It is primarily used to help the immune system recognize and attack cancer cells. At the molecular level, immunotherapy works by targeting specific proteins on cancer cells or by enhancing the body's immune response to these cells. It is classified pharmacologically as a type of biological therapy.

Investigated diseases

Follicular Lymphoma – Follicular Lymphoma is a type of non-Hodgkin lymphoma that originates from B-lymphocytes, a kind of white blood cell. It typically progresses slowly and is characterized by the formation of tumors in the lymph nodes. Over time, the disease can spread to other parts of the body, including the bone marrow and spleen. Patients may experience symptoms such as painless swelling of lymph nodes, fatigue, and night sweats. The disease often follows a pattern of periods of remission and relapse. As it advances, it may transform into a more aggressive form of lymphoma.