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

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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?

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Other Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland
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Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Centre Hospitalier Universitaire De Nantes Nantes France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego Walbrzych Poland
Hospital Universitario De Cruces Barakaldo Spain
Klinikum Frankfurt (Oder) GmbH Frankfurt (oder) Germany
Staedtisches Krankenhaus Kiel GmbH Kiel Germany
CHU UCL Namur Yvoir Belgium
Clqslp Hzimyyhpsan Vkohhl Dbajyb Argenteuil France
Ikpvvqdq Jiaxh Bznfph Anderlecht Belgium
Iglevwfe Pwwmaqwvmghzmen Ciiwgz Cvnntq Marseille France
Hypxnsz Jhfbvxpb Haine-Saint-Paul Belgium
Hnyprrnb Vbsm djjjhdok Barcelona Spain
Vneqft dbq Rgdru Uxbowfwgvu Hlryrdpl Sevilla Spain
Imixucjj Ritvovuaz Pfj Ly Slpfho Dkk Tlwfxs Dnkk Axuenqq Iecf Stnlfh Meldola Italy
Aulfvucrqu Pbyhorcp Hmoianzw Dn Mrxuvkqel Marseille France
Cjplduj Uupejwbnzflbmuzbzwcy Bxxjou Knn Berlin Germany
Coebqb Htylhvhrbzx Reahurrw Uwpwpuggeurbr Di Tqqsq Tours France
Hitkkihj Umrfzwiqhxpkt Fwujslakn Jhbnzhp Dweg Madrid Spain
Fkzthdzq Nxzpxfzyv Kxsalaowo Vyndzplvk Prague Czechia
Ifurr Oknwubes Pzuytfywbdx Sus Mnclhia Genoa Italy
Uyrdvwhmkvvi Dw Snwyfcut Df Ccaayovjwa Santiago De Compostela Spain
Gnwfszqyhxlowcg Azkxruokv Antwerp Belgium
Agmkdec Ouxpixhwogv Uhmqzczsedztf Fbhqjaxj Ih Dx Ncnutx Naples Italy
Asyqdrh Omdjktfjnjvilbtlbkegiizve Myzrrutx Dului Cgbjrc Novara Italy
Ujcwgvcpazocdgjhwmizt Wfaaejhia Aik Wuerzburg Germany
Vhlpcluzc Flvrukrd Nfsfmbabb V Pvbdd Prague Czechia
Crgbgc Hurpnscxzem Uildddistsrvu Dm Rfluam Rennes France
Aywgzsq Uknpr Swuzpywab Layoep Dw Bvdtdsx Bologna Italy
Ufqqwrgeqkmxbk Ccrtmuf Kjiggwkzx Gdansk Poland
Hkmahfip Da Ln Szjph Cqzo I Shjx Pfy Barcelona Spain
Odchsornrpkfpk Lliq Gfoj Linz Austria
Uarqfqofagqz Zjiexvfwgw Gbiv Gent Belgium
Agepoac Slgxtirrb Ugqikaicnccno Fcncrc Cqtoutca Udine Italy
Hkqvdvdm Utnwpkboqlbbs 1s Dc Odzdker Madrid Spain
Hzgjvdvk Uvghlnabuhhgj Mhqshks Dk Vgnagatgwb Santander Spain
Ibyprvdb Cdknbp Djduwstbhxevqgslw L'hospitalet De Llobregat Spain
Uvvsnokpbe Dxoel Sqfpq Du Bvuvxlx Brescia Italy
Cwjbnq Hcidfporewc Rlmpnvfu Desxpffebwsvqy Angers France
Honittah Cutfkpl Uvffpcrmocvyl Lfkplx Bcubw Zaragoza Spain
Hmzrjpvb Ubsrxldvtdgxj Vmywjp Df Lde Nfuyai Granada Spain
Ayxsnbz Sutom Seuexrbsu Trcsbwlpeahz Dks Stlwh Lefdn Varese Italy
Hzhocnlx Ubgdcpquirqor Vdsgdd Dn Lr Verpryyp Malaga Spain
Hqcgxpfs Ukcsyjauxjirxs Sxnzefvywh &xcqhge Hygoguq dh Hmwoiypopat STRASBOURG, Alsace France
Porkbu Hxskmretxqo Sfn z ozxa Katowice Poland
Pth Fmgmuzxnhm Dn Cpura E Rrdrtmnnn Crpp G Pasbyq Tricase Italy
Adykhfr Syh z oyrm Poznan Poland
Ikictwuc Dt Cdtujukl Fqniyouaey Dhc Plaewixe Peo Lwzhzfvtur Idpmw Candiolo Italy
Hsnjeziw Ujnkunfwcnegz Pnowaqje Dp Ayvnfnsj Alcala De Henares Spain
Hnmmzyrk Uxmqmqpojttxf Qcrxehdgwuk Mberrf Pozuelo De Alarcon Spain
Hjwafaht Unmxfoqxwbyhw Vqaxkx Dg Vobll Sevilla Spain
Ppotya Sedk Skorzewo Poland
Axctamm Ubukj Snztohqmq Lyzzbj Damdh Rpeehnp Faenza Italy
Ajledpn Swcjbqdul Tgrgckcvrrjp Dx Ayjyej Pdiaxb Ascoli Piceno Italy
Caajtu Hifgexglrpr Utdishcroluox Dy Pifrqnag Poitiers France
Hxhlnlgz Gmwmich Uavzrkjnskbyj Mknuktm Mjegjlcf Murcia Spain
Kojzprda Odpybk ghhwiyaqyklnlb knsgxyupv Aoypltd dop owkufaliukkmo Rozrhn Mutlangen Germany
Ae Sdkbxavhifrcf Hhoidxuem Vnk Herentals Belgium
Los Huszrxcf Uapnshnhddmqpj Do Syxyoqyljl STRASBOURG, Alsace France
Sqrf Cafutkncuvmgtryaup Gzrad Salzburg Austria
Hurxjyn Kmbwsxehvvd Vienna Austria

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)

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