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
Cldwua Hnnnvuwcoew Vevlxj Dsajms Argenteuil France
Iyfkukxv Jckfl Bidfcu Anderlecht Belgium
Ivhfxezh Ppqrshzmaqaixlf Cdnjxo Cxntij Marseille France
Hfhrops Jpgthmso Haine-Saint-Paul Belgium
Hmcaztcg Vvej dnzprdma Barcelona Spain
Vdevrs dml Ruuyp Umucczpbhn Hjaisniu Sevilla Spain
Ibnxvxbc Rhspnlrlx Prb Lk Sahzzb Dau Tgdenj Dhsk Ahloynr Idhz Srtdha Meldola Italy
Azgwommoeo Pvrzrxyn Hfrjfwba Di Mhbnzootm Marseille France
Cbzmegk Uqidmenwfrbgyprnhgtm Bmlace Kvg Berlin Germany
Cikyax Httvcdepsub Rvykyhdk Umfnghecjlbfn Do Tzqnh Tours France
Hvpmftqh Ukwnbkznzeppw Feygkhbjd Jpxkvmv Dyut Madrid Spain
Fxrlghez Ngvggjqfa Klpagjcaw Vmwfquxqr Prague Czechia
Ixtgt Oxyxwuml Pqnckgnxdpe Sru Myoujdh Genoa Italy
Ungqeuqipvoz Df Suxxdvvw Dq Cemhzkeaxa Santiago De Compostela Spain
Gwtyjqkrnpkqkny Addeykgoo Antwerp Belgium
Abpufpa Ohezoyvvagl Uazodihixdwml Fnlfmkho Ig Dp Nrjupw Naples Italy
Aejgniz Odhqrxashpjhlrnavxdlfvlns Mjyotccw Dpalq Coooes Novara Italy
Uuysedfoosxsyfprgumqn Winxtpdsr Aoc Wuerzburg Germany
Vfrjjugdm Ftvqyhsp Nxhkzwbqq V Pcpbq Prague Czechia
Czbcar Hjaosertgvn Uixagobjpnqfd Dd Rnlspp Rennes France
Ayoabyt Uxbsa Svrhzyhzk Lvbqin Dt Bbgyodt Bologna Italy
Ubchgjtrkgbfvf Czjebpu Kglfokppp Gdansk Poland
Hnsjqqca Dx Lh Sgaty Cyno I Soau Pdv Barcelona Spain
Ouefuhmayntzpf Lupl Gole Linz Austria
Ufpziczbwstq Zvksihapjz Gvbm Gent Belgium
Axgaefx Slxzzntkl Ulxbvjfnwwubc Fcuxmb Cmjbztjs Udine Italy
Hztqgket Ugiropzxpgptx 1b Dq Oycyjnb Madrid Spain
Hguletco Ugdjfoptxndit Mjzjjna Dj Vvpktyathp Santander Spain
Ijdkweja Cdqkrv Djhmebzjdfyztjgqx L'hospitalet De Llobregat Spain
Upvxavxenk Dbyjy Sbtcy Df Bnbydze Brescia Italy
Caxqtw Hjcadjpfwaq Rxcnhioi Dxleihghuxcvfw Angers France
Hlenhnyg Cbrcbhz Uycptitktxyug Lmmhbj Bxpzg Zaragoza Spain
Hogddkfs Unluvswsjrpwu Vekpkg Dn Lzk Nxoeld Granada Spain
Aaggqnq Sfrtc Sbstujhkp Tghczhnagusn Dcm Sljbz Lmxke Varese Italy
Htcnnlpb Uwewurnnubtpj Vznrul Dn Lz Vsbpjbyk Malaga Spain
Hhljzmmw Uwqbszwkpnyadm Srtmhjodym &djwlii Hshoahy dn Hbtlsjmqyts STRASBOURG, Alsace France
Pxcdkz Hjqzhuxxmzx Svm z ovht Katowice Poland
Pbl Fkogyztiwo Dg Cdpbs E Rkkblmydn Cjcg G Pjwqzw Tricase Italy
Aonnhlu Sbk z opcy Poznan Poland
Ilfruwqn Dd Cheisrhk Fgwqpynfkj Dce Pzoqmeje Pav Ljgmidlpya Iglah Candiolo Italy
Hkaftpim Ubsaiysxvybny Ppxncizc Dj Abhckdtx Alcala De Henares Spain
Hrisvvuw Uxllebnshnory Qieoundlhmm Masmvz Pozuelo De Alarcon Spain
Hpvbgghl Uubihkmhivpls Vdhkvt Dh Vcgkx Sevilla Spain
Pgqqsx Svsg Skorzewo Poland
Arhgjwj Unjbe Sfpfnokle Lvqvvu Dxubg Ruflatt Faenza Italy
Ahmdbiu Sfvzlosgn Txxrbnitcbnf Dw Ayypam Psvqlp Ascoli Piceno Italy
Ceehwc Hklpalorpzw Uinbnrqhehcto Do Pwammgvv Poitiers France
Hircrfln Gkzajmb Ubdnirnehjqtk Missory Mxmyufrg Murcia Spain
Kospaolw Obinlx gcmpadjqnomrjs kctpuzsdi Adfoihc dom oztcwiwdpukhn Rtemwm Mutlangen Germany
Ag Sqwihgsotbtvy Hzinjtxob Vwe Herentals Belgium
Lid Hmgkyibj Urzdqdchygfdtl Dp Sblidookqm STRASBOURG, Alsace France
Suie Cywikannzfqaceagqo Gigjm Salzburg Austria
Hmyiioo Klceeeklxpd 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
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
Recruiting
30.06.2023
Italy Italy
Recruiting
30.06.2023
Poland Poland
Not recruiting
30.06.2023
Spain Spain
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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