Study Comparing Odronextamab with Rituximab and Chemotherapy for Patients with Untreated Follicular Lymphoma

3 1 1 1

What is this study about?

This clinical trial is focused on studying a type of cancer called follicular lymphoma, which is a form of non-Hodgkin lymphoma. The trial is investigating a new treatment called odronextamab, also known by its code name REGN1979. Odronextamab is a special type of medication known as a bispecific antibody, which is designed to target specific proteins on cancer cells. The study aims to compare the effectiveness and safety of odronextamab with a commonly used treatment involving rituximab combined with various chemotherapy drugs, including vincristine sulfate, bendamustine hydrochloride, doxorubicin hydrochloride, cyclophosphamide, and prednisone.

The purpose of the study is to determine how well odronextamab works and how safe it is for patients who have not been treated for follicular lymphoma before. The study is divided into two parts. In the first part, the focus is on assessing the safety and tolerability of odronextamab. In the second part, participants will be randomly assigned to receive either odronextamab or the standard treatment with rituximab and chemotherapy. The study will monitor the participants over a period to see how well the treatments work in achieving a complete response, which means the disappearance of all signs of cancer.

Participants in the study will receive their assigned treatment and will be closely monitored by healthcare professionals. The study will involve regular check-ups and tests, such as imaging scans like MRI or CT scans, to track the progress of the treatment. The trial is expected to continue for several years to gather comprehensive data on the long-term effects and benefits of the treatments being studied.

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 imaging tests such as CT or MRI to document measurable disease.

2 part 1: safety run-in

The first part of the trial focuses on assessing the safety and tolerability of odronextamab. This involves monitoring for any dose-limiting toxicities and treatment-emergent adverse events.

During this phase, odronextamab is administered as an intravenous infusion. The specific dosage and frequency are determined based on individual tolerance and response.

3 part 2: randomized phase

In the second part, participants are randomly assigned to receive either odronextamab or a combination of rituximab with chemotherapy agents such as vincristine sulfate, bendamustine hydrochloride, doxorubicin hydrochloride, cyclophosphamide, and prednisone.

The chemotherapy regimen involves various routes of administration: intravenous infusion for rituximab, bendamustine hydrochloride, and doxorubicin hydrochloride; injection for vincristine sulfate; and oral tablets for prednisone.

4 treatment duration

The treatment period varies depending on the assigned group and individual response. Regular assessments are conducted to monitor the effectiveness and any side effects of the treatment.

5 follow-up and evaluation

After completing the treatment phase, follow-up visits are scheduled to evaluate the long-term effects and overall response to the treatment. This includes imaging tests and other assessments as needed.

Who Can Join the Study?

  • Must have a diagnosis of follicular lymphoma. This is a type of cancer that affects the lymphatic system.
  • The cancer must be CD20 positive. This means the cancer cells have a specific protein on their surface.
  • The cancer should be Grade 1-3a and at an advanced stage, either stage II bulky or stage III/IV. This describes the size and spread of the cancer.
  • There must be a need for treatment as outlined in the study details.
  • Must have measurable disease. This means the cancer can be seen and measured using imaging tests like CT (Computed Tomography) or MRI (Magnetic Resonance Imaging).
  • Must have an ECOG performance status of 0-2. This is a scale that measures how well a person can perform daily activities. A score of 0-2 indicates the person is fully active or has some limitations but can still care for themselves.
  • Must have adequate bone marrow function and liver function. This means the bone marrow and liver are working well enough to handle the treatment.
  • Must be within the specified age range for the study.
  • Both male and female participants are eligible.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland
Show more
Centre Hospitalier Victor Dupouy Argenteuil France
Institut Jules Bordet Anderlecht Belgium
Virgen del Rocío University Hospital Sevilla Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Gasthuiszusters Antwerpen Antwerp Belgium
Centre Hospitalier Universitaire De Nantes Nantes France
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Centre Hospitalier Universitaire De Rennes Rennes France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Universitair Ziekenhuis Gent Gent Belgium
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Universitario 12 De Octubre Madrid Spain
Universita Degli Studi Di Brescia Brescia Italy
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Hospital Universitario Virgen De La Victoria Malaga Spain
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego Walbrzych Poland
Pratia Hematologia Sp. z o.o. Katowice Poland
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Universitario Principe De Asturias Alcala De Henares Spain
Hospital Universitario De Cruces Barakaldo Spain
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Hospital Universitario Virgen De Valme Sevilla Spain
Pratia S.A. Skorzewo Poland
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Azienda Sanitaria Territoriale Di Ascoli Piceno Ascoli Piceno Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Klinikum Frankfurt (Oder) GmbH Frankfurt (oder) Germany
Staedtisches Krankenhaus Kiel GmbH Kiel Germany
Hospital General Universitario Morales Meseguer Murcia Spain
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts Mutlangen Germany
AZ St.-Elisabeth Herentals VZW Herentals Belgium
CHU UCL Namur Yvoir Belgium
Les Hopitaux Universitaires De Strasbourg STRASBOURG, Alsace France
SCRI CCCITGEMEINNÜTZIGE GMBH. Salzburg Austria
Hanusch Krankenhaus Vienna Austria
Itgnsfmx Pfcdtjzkgkvioxn Cwiefy Csehms Marseille France
Hmgmovo Jotayoht Haine-Saint-Paul Belgium
Hxbvcofk Vych dvfuvwoj Barcelona Spain
Ibehaznb Reiyrujwo Pmy La Stlydv Dcn Tjfruj Dfll Amwahfv Ivqy Sqvbjw Meldola Italy
Agwzfuicmh Puzjsxhw Hofjpkjy Dh Mrooagpoe Marseille France
Ccpdpo Hvvuyvsusxm Rmymwasy Umtzwcschqlwe Dy Tlzue Tours France
Uekktuxvlujquyqslpjep Wwsmjyqtl Amg Wuerzburg Germany
Abamabh Ulxut Sodokzcze Ldfaea Do Bozusqu Bologna Italy
Ulogwhiksejlfs Cxrdnfy Kbvcospgy Gdansk Poland
Hzgmaoiv Df Ld Shevd Cnqh I Sxeh Pvo Barcelona Spain
Ovmfzmvkuitheu Lufc Gruf Linz Austria
Hzutaupt Uhucleeswwbrn Mypvugk Dx Vapzchmfvp Santander Spain
Izbpatll Czgsxr Dlhxygoqqyoavodzc L'hospitalet De Llobregat Spain
Cbyjrx Hxmjlrzckxy Rxhplbhy Dsbcatmkzzayln Angers France
Wsppxplhled Wnbhslovlbihchtailds Cvlygdm Orgqitesl I Tqqpjqeficqag Ik Mikviwaasum W Llefv Lodz Poland
Hsjfodfz Uawvpgveefnuwy Sxcmxxahwn &xevurq Hxsyphi dl Hwndkzltfds STRASBOURG, Alsace France
Aqtilag Sja z oeea Poznan Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
30.06.2023
Belgium Belgium
Not recruiting
30.06.2023
Czechia Czechia
Not recruiting
30.06.2023
France France
Not recruiting
30.06.2023
Germany Germany
Not recruiting
30.06.2023
Italy Italy
Not recruiting
30.06.2023
Poland Poland
Not recruiting
30.06.2023
Spain Spain
Not recruiting
30.06.2023

Trial locations

Odronextamab (REGN1979) is a bispecific antibody designed to target two specific proteins, CD20 and CD3. It is used in this clinical trial to treat patients with follicular lymphoma who have not received prior treatment. The medication works by engaging the immune system to attack and destroy cancer cells. It is being studied for its safety, how well it is tolerated, and its effectiveness in achieving a complete response in patients.

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 progress over time, sometimes transforming into a more aggressive form of lymphoma. Symptoms may include fatigue, night sweats, and unexplained weight loss. It is often diagnosed in older adults and can be found in multiple lymph nodes or organs at the time of diagnosis. The progression of follicular lymphoma can vary greatly among individuals, with some experiencing long periods without symptoms.

Trial ID:
2022-502660-20-00
Protocol code:
R1979-HM-2298
NCT ID:
NCT06091254
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of LY3484356 (imlunestrant) with Tamoxifen Citrate and Goserelin Acetate in Premenopausal Women with ER‑Positive, HER2‑Negative Early Breast Cancer

    Recruiting

    2 1 1 1
    Investigated Diseases:
    Belgium France Germany Italy
  • Cevostamab, Pomalidomide and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma Previously Treated with 1‑3 Lines of Therapy

    Recruiting

    3 1 1 1
    Investigated Diseases:
    Czechia Denmark France Germany Greece Italy +2