Ongoing Clinical Trials for Non-Hodgkin’s Lymphoma Unspecified Histology Aggressive
There are currently 2 clinical trials exploring new treatments for aggressive non-Hodgkin’s lymphoma. These studies are investigating odronextamab, a bispecific antibody designed to help the immune system target and attack cancer cells more effectively. Trials are taking place across multiple European countries, offering opportunities for patients whose disease has not responded to standard treatments or has returned after initial therapy.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Espagne
- France
- Germany
- Hungary
- Italy
- Netherlands
- Poland
- Romania
- Spain
Study on the Effectiveness and Safety of Odronextamab Compared to Standard Treatment in Adults with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
This trial is comparing a new medication called odronextamab with the standard treatments currently used for aggressive B-cell lymphoma that has returned or not responded to initial therapy. Odronextamab is a bispecific antibody, which means it is designed to target two different proteins at once, helping the immune system better identify and attack cancer cells.
Main inclusion criteria: Patients must have aggressive B-cell lymphoma confirmed by laboratory tests, with tumor tissue available for central testing. The cancer must have either not responded to initial treatment or returned within 12 months of starting it. The first treatment should have included an anti-CD20 antibody and an anthracycline medication. Patients need to have tumors that can be measured on scans, with at least one lymph node larger than 1.5 cm or another tumor larger than 1.0 cm. Participants should be planning to undergo an autologous stem cell transplant and have a performance status of 0 or 1, meaning they are either fully active or only restricted in strenuous activities. Adequate blood and organ function is required.
Main exclusion criteria: Patients with cancer types other than B-cell lymphoma cannot participate. Those outside the specified age range, those unable to follow study procedures or take medications as required, or those with medical conditions that might interfere with the study or make participation unsafe are also excluded. Vulnerable populations requiring special protection are not eligible.
Focus and goal: The trial aims to determine how long participants can live without their cancer worsening, known as event-free survival. Researchers will also study overall survival rates, quality of life changes, and how patients’ bodies respond to the treatments. The study involves several months of closely monitored treatment to assess effectiveness and safety.
Investigational drugs: The main treatment being tested is odronextamab, which targets both CD20 and CD3 proteins. It is compared against standard treatments including cisplatin, gemcitabine, carboplatin, dexamethasone, cytarabine, rituximab, etoposide, and ifosfamide. All medications except dexamethasone are given through intravenous infusion directly into the bloodstream.
Study on the Effects and Safety of Odronextamab for Adults with Previously Treated B-cell Non-Hodgkin Lymphoma
This clinical trial is evaluating odronextamab in patients with various types of B-cell lymphoma, including follicular lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma, and marginal zone lymphoma. The study focuses on patients whose cancer has returned or not responded to previous treatments.
Main inclusion criteria: Patients must have a confirmed diagnosis of B-cell lymphoma with specific requirements for each subtype. For follicular lymphoma grades 1-3a, patients must have had at least 2 previous treatments fail. For diffuse large B-cell lymphoma, the same requirement applies. Mantle cell lymphoma patients need at least one previous treatment and must have been treated with a BTK inhibitor. Marginal zone lymphoma patients require at least 2 prior treatments. All participants need measurable disease visible on imaging tests such as CT or MRI scans. Patients must have a performance status of 0 or 1 and good bone marrow, liver, and kidney function. The disease should require treatment at the time of joining the study.
Main exclusion criteria: Patients with cancer types other than B-cell lymphoma are excluded. Those who have not tried the required number of previous treatments for their specific lymphoma subtype cannot participate. Patients younger than 18 or older than 65 years of age, and those unable to understand or agree to study requirements are not eligible.
Focus and goal: The study aims to evaluate how well odronextamab works in shrinking tumors and to assess its safety profile. Researchers will monitor patients over time to measure anti-tumor activity and track any side effects. Regular imaging tests and health evaluations will be conducted throughout the treatment period and during follow-up to understand the duration of response and long-term effects.
Investigational drug: Odronextamab is a bispecific antibody that attaches to both CD20 and CD3 proteins. This design helps the immune system recognize and destroy cancer cells. The medication is administered as an intravenous infusion, with dosage and frequency determined by the study protocol and adjusted based on individual response and tolerance.
Summary
Both ongoing trials are investigating the same medication, odronextamab, for treating aggressive B-cell lymphoma in patients who have already received previous treatments. The first trial directly compares odronextamab with standard chemotherapy regimens, while the second focuses solely on evaluating odronextamab’s effectiveness and safety across different lymphoma subtypes.
These studies are available across multiple European countries, with particularly strong representation in Germany, Poland, Italy, and Spain. Both trials require that patients have measurable disease and adequate organ function, but differ in their specific treatment history requirements depending on the lymphoma subtype.
The concentration of both trials on odronextamab reflects growing interest in bispecific antibodies as a potential treatment option for patients whose lymphoma has not responded to conventional therapies. This approach represents a newer strategy in cancer treatment, aiming to harness the body’s own immune system to fight cancer cells more effectively.
