A study comparing odronextamab combined with chemotherapy versus rituximab combined with chemotherapy in adults with previously untreated follicular lymphoma

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What is this study about?

This study involves people with Follicular lymphoma, which is a type of cancer that affects the lymphatic system, a part of the body that helps fight infections. The study is looking at two different treatment approaches. One treatment uses Odronextamab, also known as REGN1979, which is a type of medicine that helps the immune system recognize and attack cancer cells. The other treatment uses rituximab, which is an existing medicine that also targets cancer cells. Both of these medicines are given in combination with chemotherapy, which includes various drugs such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone, and prednisolone. These chemotherapy drugs work in different ways to stop cancer cells from growing and multiplying.

The purpose of this study is to compare how well odronextamab combined with chemotherapy works compared to rituximab combined with chemotherapy in people who have not received treatment for their follicular lymphoma before. The study will also look at whether odronextamab is safe and what side effects it may cause. The study is divided into two parts. Part 1 will test the safety of odronextamab when given with chemotherapy and will help determine the best dose to use. Part 2 will compare the two treatment combinations to see which one works better at helping patients achieve a complete response, which means that signs of cancer can no longer be detected.

During the study, participants will receive their assigned treatment through an infusion into a vein or by mouth, depending on the specific medicine. The study will monitor participants through various tests including imaging scans such as computed tomography or magnetic resonance imaging to measure how the disease responds to treatment. Participants will also be asked to complete questionnaires about their quality of life and any symptoms they experience. The study will track how long the cancer stays under control, whether it comes back, and how long participants live. Blood samples will be taken to measure drug levels in the body and to check if the body develops any immune response to the treatment.

1 Initial treatment phase with combination therapy

During this phase, treatment will be received with either odronextamab combined with chemotherapy or rituximab combined with chemotherapy. The specific combination assigned will be determined randomly.

The chemotherapy regimen will consist of cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and either prednisolone or prednisone. This combination is commonly referred to as CHOP or CVP chemotherapy.

Odronextamab or rituximab will be administered through an intravenous infusion, which means the medication will be delivered directly into a vein over a period of time.

Cyclophosphamide and doxorubicin hydrochloride will be given through intravenous administration, delivered directly into a vein.

Vincristine sulfate will be administered by injection.

Prednisolone or prednisone will be taken orally, meaning by mouth in pill or liquid form.

The exact dosages, frequency of administration, and duration of this treatment phase will be determined based on the specific protocol requirements and individual medical assessment.

2 Regular monitoring and assessment visits

Throughout the treatment period, regular visits will be scheduled to monitor response to therapy and assess any side effects.

During these visits, imaging tests such as computed tomography scans or magnetic resonance imaging may be performed to evaluate how the lymphoma is responding to treatment.

Blood tests will be conducted to monitor bone marrow function and liver function.

Physical examinations will be performed to assess overall health status and any changes in symptoms.

Any side effects or adverse reactions experienced will be documented and evaluated by the medical team.

3 Response evaluation at designated timepoints

At specific timepoints during and after treatment, formal assessments will be conducted to determine how well the lymphoma has responded to therapy.

A key evaluation will occur at 30 months to determine if a complete response has been achieved, meaning that no signs of lymphoma can be detected.

These evaluations will include imaging studies reviewed by independent specialists to provide an objective assessment of treatment response.

The medical team will also assess disease progression and overall survival throughout the study period.

4 Quality of life assessments

At various points during the trial, questionnaires will be completed to assess physical functioning, overall quality of life, and treatment-related symptoms.

These assessments will help evaluate how the treatment affects daily activities and overall well-being.

The questionnaires will ask about general health status, lymphoma-specific symptoms, and any burden from treatment side effects.

Responses to these questionnaires will be used to understand the impact of treatment from a patient perspective.

5 Long-term follow-up period

After completing the active treatment phase, ongoing follow-up visits will continue to monitor long-term outcomes.

During this period, assessments will focus on whether the lymphoma remains in remission or if any signs of disease progression appear.

The time until any additional lymphoma treatment becomes necessary will be tracked.

Long-term safety monitoring will continue to identify any delayed side effects from the treatment received.

This follow-up period may extend for several years to fully evaluate the durability of treatment response and overall survival.

6 Laboratory monitoring for immune response

Throughout the trial, blood samples will be collected to measure odronextamab levels in the bloodstream.

These samples will also be tested to determine if the body has developed any antibodies against odronextamab, which are proteins the immune system might produce in response to the medication.

If antibodies are detected, additional testing will determine if they are neutralizing antibodies, which could potentially affect how well the medication works.

This monitoring will occur both during the period when odronextamab is given with chemotherapy and when it is administered alone.

Who Can Join the Study?

  • You must have a diagnosis of follicular lymphoma, which is a type of cancer that affects white blood cells called lymphocytes, with specific characteristics: positive for a marker called CD20 and classified as grade 1-3a, stage II bulky (large tumor mass) or stage III/IV (more advanced spread)
  • You must have measurable disease that can be seen on imaging scans such as CT scan (a special X-ray that takes detailed pictures of the inside of your body) or MRI scan (a scan that uses magnets and radio waves to create pictures of your body)
  • You must have an ECOG performance status of 0-2, which is a score that measures how well you can perform daily activities and care for yourself, where 0 means you are fully active and 2 means you are able to care for yourself but cannot work
  • You must have adequate bone marrow function, meaning your bone marrow (the soft tissue inside bones that makes blood cells) must be working well enough to produce blood cells
  • You must have adequate hepatic function, meaning your liver must be working properly
  • Other requirements as specified in the study protocol may also apply

Who Cannot Join the Study?

  • The study does not list specific exclusion criteria in the provided information. Please consult with the research team or your doctor to learn about all conditions or situations that might prevent you from participating in this clinical trial.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Site Name City Country Status
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Medical University Of Graz Graz Austria
Hospital Universitario De Navarra Pamplona Spain
Medical University Of Vienna Vienna Austria
Hospital Universitario De Salamanca Salamanca Spain
Gemeinschaftspraxis Haematologie Onkologie Dresden Germany
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Assistance Publique Hopitaux De Paris Paris France
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego Walbrzych Poland
Centre Hospitalier Du Puy Le Puy-En-Velay France
Chorale Du Centre Hospitalier De Lens Lens France
Centre Hospitalier Victor Dupouy Argenteuil France
Centre Hospitalier De Cannes Simone Veil Cannes France
Institut Jules Bordet Anderlecht Belgium
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Virgen del Rocío University Hospital Sevilla Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Hospital Universitario De Cruces Barakaldo Spain
Kepler Universitaetsklinikum GmbH Linz Austria
Pratia S.A. Skorzewo Poland
Hospital Universitario Lucus Augusti Lugo Spain
Centre Hospitalier Universitaire De Nantes Nantes France
In Vivo Sp. z o.o. Bydgoszcz Poland
Hopital NOVO Pontoise France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre Hospitalier Universitaire De Nimes Nimes France
Universita’ Degli Studi Di Modena E Reggio Emilia Modena Italy
Universitair Ziekenhuis Gent Gent Belgium
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Staedtisches Krankenhaus Kiel GmbH Kiel Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Klinikum Wels-Grieskirchen GmbH Wels Austria
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Vitaz Sint-Niklaas Belgium
Hospital Universitario Infanta Leonor Madrid Spain
CHR Verviers Verviers Belgium
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie Homburg Germany
Centre Hospitalier Universitaire De Caen Normandie Caen France
Hôpital Pontchaillou-CHU Rennes Rennes France
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Azienda Sanitaria Locale Roma 2 Rome Italy
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources Mont-de-Marsan France
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Centre Hospitalier Saint Nazaire St Nazaire France
CHU UCL Namur Yvoir Belgium
Pratia Hematologia Sp. z o.o. Katowice Poland
Pukd Tovhy Hlukwywp Ukwdohekdjto Sabadell Spain
Iiwnxyta Rndntjqrh Psg Lr Stmbkt Dlp Tympxd Dsrb Abmqmpn Igop Sjpemx Meldola Italy
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Akwbxbl Ukj Igoiw Dp Rqyczy Ebcniw Reggio Emilia Italy
Avbailx Orstatxyvto Rhaoulygb Sfa Cggbj Potenza Italy
Tiiac Kofwhjaw Gmxz Innsbruck Austria
Szinzqgyzeqaipij Kfeguvfgvwlieqfk Ggyhwaodlq Leoben Austria
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Hntxuhww Uceecemkdvvls Mnpwg Thjnhbvq Terrassa Spain
Ajihxlx Saq z ohdx Poznan Poland
Caemnn Hcsgwrtflby Razkczxq Uddwxdikoqfvq Dt Tmoif Tours France
Uumckkbghxgtyb Clwbqcp Kkdhgiznp Gdansk Poland
Cbjfts Losv Brysab Lyon France
Uhhrjotbgumlxswrzqwhp Ewfbg Afi Essen Germany
Uqknvyhqxt Dutkp Saaix Di Roij Lt Sryfxtbf Rome Italy
Wsjfqpbupgb Wnfisyyaqfhbkwchyuft Ceypwww Oyktinmeo I Tzidhnzxollkn Iq Mzszarrlzjl W Lvpkd Lodz Poland
Iujraonv Cxvurz Detzaehfeiovymjuv L'hospitalet De Llobregat Spain
Inpminuc dc Cdoqqlyjgpkg Hzfzwxqogzw Ummkrbdogfzjz dj Sjmvc Eonggst (yppbdac Saint Priest En Jarez France
Imitktif Picynfwfpybkpum Czevav Cjenzs Marseille France
Aoapzbm Oqbaklomxmh Uwbklfdodwcdq Cjmbtzfyiapv Dmmpb Sqroeh E Dkupx Shvcost Dr Tkpfwg Turin Italy

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
18.08.2023
Belgium Belgium
Recruiting
18.08.2023
Czechia Czechia
Recruiting
18.08.2023
France France
Recruiting
18.08.2023
Germany Germany
Not yet recruiting
18.08.2023
Italy Italy
Recruiting
18.08.2023
Poland Poland
Recruiting
18.08.2023
Spain Spain
Recruiting
18.08.2023

Trial locations

Odronextamab is a bispecific antibody medication that works by connecting two different types of proteins on cells. It attaches to CD20 proteins found on certain cancer cells and CD3 proteins found on immune system cells, helping the body’s immune system recognize and attack the cancer cells. In this trial, it is being tested in combination with chemotherapy to treat follicular lymphoma.

Rituximab is a medication used to treat certain types of cancer, including follicular lymphoma. It works by targeting CD20 proteins on the surface of cancer cells, marking them so the immune system can find and destroy them. In this trial, it is being used in combination with chemotherapy as a comparison treatment.

CHOP is a combination of chemotherapy drugs used to treat lymphoma. The letters stand for the different medicines included in this treatment regimen. It works by killing cancer cells or stopping them from growing.

CVP is another combination of chemotherapy drugs used to treat lymphoma. Like CHOP, the letters represent the different medicines in this treatment combination. It also works by killing cancer cells or preventing them from multiplying.

Follicular lymphoma – Follicular lymphoma is a type of cancer that affects the lymphatic system, which is part of the body’s immune system. It develops when white blood cells called B-lymphocytes grow abnormally and accumulate in the lymph nodes and other organs. The disease is characterized by the formation of abnormal clusters of cells called follicles within the lymph nodes. Follicular lymphoma typically grows slowly and may be present for months or years before symptoms appear. Common signs include painless swelling of lymph nodes in the neck, armpits, or groin, along with fatigue, night sweats, and unexplained weight loss. The disease can remain stable for long periods, but it may also progress or transform into a more aggressive form of lymphoma over time.

Trial ID:
2022-502113-28-00
Protocol code:
R1979-ONC-2075
Trial Phase:
Therapeutic confirmatory (Phase III)

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