Non Hodgkin Lymphoma Clinical Trial
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma
Summary
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Around 642 adult participants with R/R FL will be enrolled in approximately 300 sites across the world.
Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days).
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
Participant has:
Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
>= 1 measurable nodal lesion (long axis >= 1.5 cm and short axis > 1.0 cm) or >= 1 measurable extra-nodal lesion (long axis >= 1.0 cm) on CT scan or MRI.
Histologically confirmed Grade 1 to 3a follicular lymphoma (FL) according to the World Health Organization (WHO) 2016 classification with no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy and CD20+ on a representative tumor biopsy based on the pathology report.
Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with (an)other anti-lymphoma agent(s).
Eligible to receive R2 per investigator determination.
Exclusion Criteria:
Documented refractoriness to lenalidomide.
Have lenalidomide exposure within 12 months prior to randomization.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 121 Locations for this study
Camperdown New South Wales, 2050, Australia
Kingswood New South Wales, 2747, Australia
Douglas Queensland, 4814, Australia
Murdoch Western Australia, 6150, Australia
Perth Western Australia, 6000, Australia
Langwarrin , 3910, Australia
Sankt Poelten Niederoesterreich, 3100, Austria
Linz Oberoesterreich, 4010, Austria
Salzburg , 5020, Austria
Edegem Antwerpen, 2650, Belgium
Leuven Vlaams-Brabant, 3000, Belgium
La Louvière , 7100, Belgium
Liege , 4000, Belgium
Sint-Niklaas , 9100, Belgium
Turnhout , 2300, Belgium
Victoria British Columbia, V8R 6, Canada
Rimouski Quebec, G5L 5, Canada
Hradec Kralove , 500 0, Czechia
Herning Midtjylland, 7400, Denmark
Vejle Syddanmark, 7100, Denmark
Clermont Auvergne-Rhone-Alpes, 63100, France
Pierre Benite CEDEX Auvergne-Rhone-Alpes, 69495, France
Rennes Bretagne, 35000, France
Dijon Cote-d Or, 21000, France
Limoges CEDEX 1 Franche-Comte, 87042, France
Nimes CEDEX 9 Gard, 30029, France
Pessac Gironde, 33604, France
Lille Hauts-de-France, 59037, France
Reims CEDEX Marne, 51092, France
Vandoeuvre-les-Nancy Meurthe-et-Moselle, 54500, France
Nantes Pays-de-la-Loire, 44000, France
Lyon CEDEX 08 Rhone, 69373, France
Poitiers Vienne, 86000, France
Caen , 14033, France
Creteil , 94000, France
Paris , 75010, France
Paris , 75013, France
Toulouse Cedex 9 , 31059, France
Athens Attiki, 11527, Greece
Athens Attiki, 11528, Greece
Athens Attiki, 12462, Greece
Athens , 10676, Greece
Ioannina , 45500, Greece
Thessaloniki , 54636, Greece
Thessaloniki , 54639, Greece
Debrecen Hajdu-Bihar, 4032, Hungary
Kaposvár Somogy, 7400, Hungary
Nyiregyhaza Szabolcs-Szatmar-Bereg, 4400, Hungary
Szombathely Vas, 9700, Hungary
Budapest , 1085, Hungary
Budapest , 1097, Hungary
Budapest , 1122, Hungary
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Be'Er Ya'Akov , 70300, Israel
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Petakh Tikva , 49414, Israel
Safed , 13100, Israel
Rome Lazio, 00168, Italy
Milan Milano, 20141, Italy
Candiolo Torino, 10060, Italy
Alessandria , 15121, Italy
Brescia , 25123, Italy
Napoli , 80131, Italy
Novara , 28100, Italy
Palermo , 90146, Italy
Seongnam Gyeonggido, 13620, Korea, Republic of
Busan , 47392, Korea, Republic of
Busan , 49201, Korea, Republic of
Busan , 49241, Korea, Republic of
Daegu , 41931, Korea, Republic of
Jeonju , 54907, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Hoorn Nh Noord-Holland, 1624 , Netherlands
Dordrecht Zuid-Holland, 3318 , Netherlands
Amsterdam , 1091 , Netherlands
Deventer , 7416 , Netherlands
Goes , 4462 , Netherlands
Groningen , 9713 , Netherlands
Nieuwegein , 3435 , Netherlands
Rotterdam , 3045 , Netherlands
Papatoetoe Auckland, 2025, New Zealand
Takapuna Auckland, 0622, New Zealand
Palmerston North Manawatu-Wanganui, 4442, New Zealand
Krakow Malopolskie, 30-72, Poland
Gdynia Pomorskie, 81-51, Poland
Kielce Swietokrzyskie, 25-73, Poland
Pila Wielkopolskie, 64-92, Poland
Skorzewo Wielkopolskie, 60-18, Poland
Pretoria Gauteng, 0044, South Africa
Santander Cantabria, 39008, Spain
Pamplona Navarra, 31008, Spain
Barcelona , 08003, Spain
Barcelona , 08041, Spain
Caceres , 10003, Spain
Cordoba , 14004, Spain
Madrid , 28027, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Salamanca , 37711, Spain
Sevilla , 41013, Spain
Lulea Norrbottens Lan, 971 8, Sweden
Boras Vastra Gotalands Lan, 501 8, Sweden
Linkoping , 581 8, Sweden
Aarau Aargau, 5001, Switzerland
St. Gallen Sankt Gallen, 9007, Switzerland
Bellinzona Ticino, 6500, Switzerland
Kaohsiung City Kaohsiung, 833, Taiwan
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Tainan , 704, Taiwan
Ankara , 06620, Turkey
Antalya , 07059, Turkey
Diyarbakir , 21200, Turkey
Istanbul , 34899, Turkey
Izmir , 35040, Turkey
Kocaeli , 41380, Turkey
Samsun , 55200, Turkey
How clear is this clinincal trial information?