Not recruiting

Phase II Study of ME-401, Rituximab and Bendamustine as First‑Line Treatment for High‑Risk and Low‑Risk Follicular Lymphoma 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

Follicular Lymphoma is a slow‑growing cancer that starts in the cells of the lymph nodes, which are part of the body’s immune system. In this study, patients are divided into two groups based on how aggressive the disease appears. Those with a higher risk receive a combination of an oral capsule called ME-401, a medicine given through a vein called rituximab, and another intravenously administered drug named bendamustine. Patients with a lower risk are randomly assigned to receive either rituximab alone or the same drug together with ME-401.

The purpose of the trial is to find out whether adding ME-401 to the standard first‑line treatment can improve outcomes for people with this type of lymphoma. This is a phase II study, meaning it is an early stage trial that looks at how well the new combination works and how safe it is.

Participants take the oral capsule daily and receive the intravenous medicines during scheduled treatment cycles that last a few weeks each. Between cycles, regular clinic visits are made for doctors to check blood tests, look for side effects, and assess how the disease is responding. After the treatment period, follow‑up appointments continue for several months to monitor long‑term health and any changes in the lymphoma.

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 enrollment and baseline assessment
After joining the study, you will provide informed consent and undergo baseline medical assessments to determine eligibility and risk classification.
Risk classification will decide whether you receive the combination of ME-401 with rituximab and bendamustine (high‑risk) or rituximab with or without ME-401 (low‑risk).
Step 2
Start of treatment
On the first treatment day you will receive an intravenous (iv) infusion of rituximab at a dose of 375 mg per square meter of body surface area (mg/m²).
If you are in the high‑risk group, you will also receive an iv infusion of bendamustine at a dose of 90 mg/m².
You will begin taking the oral capsule ME-401 60 mg by mouth; the capsule is taken according to the study schedule, typically once daily.
Step 3
Repeated treatment cycles
The iv infusions of rituximab (375 mg/m²) and, when applicable, bendamustine (90 mg/m²) will be repeated in subsequent cycles as defined by the protocol.
The oral ME-401 60 mg capsule will be taken continuously during the treatment period, following the same daily schedule.
Step 4
Regular monitoring visits
Throughout the treatment phase you will attend scheduled clinic visits for safety checks, blood tests, and imaging studies to evaluate the response of the follicular lymphoma.
Any side effects or adverse events will be recorded and managed according to study guidelines.
Step 5
Completion of treatment
After the final scheduled cycle, the administration of rituximab, bendamustine, and ME-401 will be stopped.
You will receive instructions for any necessary post‑treatment care.
Step 6
Post‑treatment follow‑up
Following the end of treatment, you will continue to attend follow‑up visits for up to 24 months to assess event‑free survival and other study outcomes.
These visits may include physical examinations, laboratory tests, and imaging to monitor disease status.

Who can join the trial?

6 criteria

Written informed consent according to ICH‑GCP guidelines – you must sign a form that shows you understand the study; ICH‑GCP is an international standard for how clinical trials protect participants.
Age between 18 and 80 years inclusive.
Having a diagnosis that is histologically confirmed (checked under a microscope) of follicular lymphoma that is not the aggressive “grade 3B” type, and the disease must be at stage II‑IV (meaning it has spread beyond the first lymph node area) and not suitable for radiotherapy (external radiation treatment). A tissue sample should preferably come from a surgical biopsy or a core biopsy (a small cylinder of tissue), while a fine‑needle sample is not acceptable.
At least one measurable lesion (a spot of disease you can see on imaging) must be present, with the longest side longer than 15 mm (about the width of a pencil eraser).
A WHO performance status of 0‑2 – this is a simple rating of how well you can carry out daily activities, where 0 means fully active and 2 means able to do self‑care but unable to work.
Having at least one reason that doctors say treatment is needed, such as: symptomatic disease (you feel sick because of the lymphoma), organ or vascular compression (the disease is pressing on an organ or blood vessel), ascites (fluid buildup in the abdomen) or pleural effusion (fluid around the lungs), bulky disease (a mass that is 6 cm or larger, about the size of a small apple), steady, noticeable growth of any tumor over at least 3 months, B‑symptoms (significant weight loss of more than 10 % in 6 months, severe night sweats, or fever over 38 °C not caused by infection), or blood problems caused by the lymphoma such as anemia (low hemoglobin below 100 g/L) or thrombocytopenia (low platelet count below 100 × 10⁹/L).

Who cannot join the trial?

19 criteria

Having a type of lymphoma that does not have the CD20 protein (called CD20‑negative lymphoma).
Having major organ problems that are not caused by the lymphoma.
Having a known history of liver damage caused by medicines, alcohol‑related liver disease, a condition called primary biliary cirrhosis, ongoing blockage of the bile ducts from gallstones, liver cirrhosis, or high blood pressure in the liver’s portal vein.
Having any past or present hepatitis B infection (based on blood tests or DNA).
Having a past hepatitis C infection that is still active; you must be negative for HCV‑RNA.
Having other serious medical illnesses that are expected to shorten life to less than one year for reasons unrelated to lymphoma.
Having another cancer within the past two years, except certain skin cancers, superficial bladder cancer, low‑grade prostate cancer that does not need treatment, cervical carcinoma in situ, or other non‑invasive/indolent cancers.
Having a psychiatric disorder or dementia that prevents you from giving informed consent or following the study schedule.
Being pregnant or breastfeeding.
Being HIV positive.
Not agreeing to use an acceptable birth control method during treatment and for six months after it ends (for men and women who could become pregnant).
Having lymphoma that has changed into a fast‑growing (aggressive) form, including grade 3B follicular lymphoma, at the start of the study or in the past.
Having lymphoma that has spread to the central nervous system (brain or spinal cord) at the start of the study or in the past.
Having received any systemic anti‑lymphoma treatment such as chemotherapy or antibody therapy before the study (steroids for symptom control are allowed).
Having received anti‑lymphoma radiation therapy within three months before starting the study (earlier local radiation is allowed).
Having poor bone‑marrow function, shown by very low neutrophil count (<1.0 × 10⁹/L) or platelet count (<50 × 10⁹/L), unless it is caused by the lymphoma itself.
Having severe heart disease, defined as New York Heart Association class III or IV (meaning marked limitation of physical activity or inability to carry out any physical activity).
Having impaired liver function not caused by lymphoma, defined as total bilirubin more than twice the normal upper limit (or more than three times if you have Gilbert’s syndrome) or ALT/AST enzymes more than three times the normal limit.
Having reduced kidney function with an estimated glomerular filtration rate (eGFR) less than 40 mL/min (using the Cockcroft‑Gault formula), unless it is due to lymphoma.

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Verified sites

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

Karolinska University Hospital
Verified
Solna, Sweden
Region Oestergoetland
Responsive
Linkoping, Sweden
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Verified
Gothenburg, Sweden

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Investigated drugs

ME-401
is an experimental oral capsule taken by mouth. In this study it is being added to the standard treatment to see if it can improve how well patients with follicular lymphoma respond when they start therapy for the first time.
Rituximab
is a medicine given through an IV infusion. It works by attaching to a protein on certain lymphoma cells and helping the immune system destroy them. In this trial it is part of the standard background regimen that all participants receive.
Bendamustine
is a chemotherapy drug also given by IV infusion. It kills cancer cells by interfering with their DNA. In this study it is used together with rituximab as the usual background treatment for follicular lymphoma.

What is already known about the treatment

ME-401
ME-401 is taken as an oral micronised capsule of 60 mg that is swallowed with water. It is an investigational drug still being studied in clinical trials and is not yet approved for routine use. The medication is being tested for the treatment of follicular lymphoma, both in high‑risk and low‑risk patients. It works by blocking the PI3Kδ enzyme, which helps stop the growth signals that keep malignant B‑cells alive, and it is classified as an oral PI3Kδ inhibitor.
Rituximab
Rituximab is given by intravenous infusion, usually over several hours. It is an approved monoclonal antibody that has been used for many years in the treatment of follicular lymphoma and other B‑cell cancers. The drug binds to the CD20 protein on the surface of B‑cells, marking them for destruction by the immune system. It belongs to the class of anti‑CD20 monoclonal antibodies.
Bendamustine
Bendamustine is administered through an IV infusion directly into the bloodstream. It is an approved chemotherapy agent that is commonly used for follicular lymphoma and other blood cancers. The medication works as an alkylating agent, attaching to DNA inside cancer cells and causing the DNA to break, which leads to cell death. It is classified as an alkylating chemotherapy drug.

Investigated diseases

Follicular lymphoma - Follicular lymphoma is a type of non‑Hodgkin lymphoma that starts from B‑cells in the lymph nodes. It usually grows slowly and may cause painless swelling of lymph nodes. Over time the disease can spread to other lymph node areas and sometimes to the bone marrow or spleen. The pattern is generally indolent, but the number of abnormal cells can increase gradually. Some patients may experience periods where the disease becomes more active before stabilizing again. The condition is characterized by a gradual accumulation of cancerous cells in the lymphatic system.