Study of Tafasitamab, Lenalidomide, and Rituximab for Patients with Relapsed or Refractory Follicular or Marginal Zone Lymphoma

3 1 1

What is this study about?

This clinical trial is focused on studying two types of blood cancers: follicular lymphoma and marginal zone lymphoma. These are conditions where the body’s lymphatic system, which is part of the immune system, is affected. The study is testing the effectiveness of a combination of medications to treat these diseases. The medications being studied include tafasitamab, lenalidomide, and rituximab. Tafasitamab is a type of protein that helps the immune system target cancer cells, while lenalidomide is a drug that affects the immune system and helps slow the growth of cancer cells. Rituximab is another medication that targets specific cells in the immune system. The study will compare the effects of these medications together against a combination of lenalidomide and rituximab alone.

The purpose of the study is to see if adding tafasitamab to the treatment makes it more effective for patients whose cancer has returned or has not responded to previous treatments. Participants in the study will receive either the combination of tafasitamab, lenalidomide, and rituximab or a combination of lenalidomide and rituximab, along with a placebo. The study will monitor the participants over a period to see how well the cancer responds to the treatment and to check for any side effects.

Throughout the study, participants will receive the medications through different methods. Tafasitamab and rituximab are given as an infusion, which means they are delivered directly into the bloodstream through a vein. Lenalidomide is taken orally in the form of capsules. The study aims to provide valuable information on whether the addition of tafasitamab can improve treatment outcomes for patients with these types of lymphoma.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving the study treatment or the placebo.

2 initial treatment phase

If you are in the group receiving the study treatment, you will receive rituximab through an intravenous infusion. This means the medication will be given directly into your vein. The dosage is 100 mg, and the frequency and duration will be determined by the study protocol.

You will also take lenalidomide in the form of hard capsules. The dosage may vary, including 5 mg, 10 mg, 15 mg, or 20 mg capsules, taken orally. The specific dosage and frequency will be provided by the study team.

3 additional treatment phase

In addition to rituximab and lenalidomide, you may receive tafasitamab if you are in the study treatment group. Tafasitamab is administered as a 200 mg solution for infusion, given intravenously.

The duration and frequency of these treatments will be specified by the study protocol and communicated to you by the study team.

4 placebo group

If you are in the placebo group, you will receive a saline solution infusion. This is a 0.9% sodium chloride solution, which is a standard saltwater solution used in medical settings. It will be administered in a similar manner to the study medications.

5 monitoring and follow-up

Throughout the study, your health and response to the treatment will be closely monitored. This includes regular check-ups, blood tests, and other assessments as required by the study protocol.

The study team will provide you with all necessary information regarding the schedule and procedures for these follow-up visits.

6 end of study

At the end of the study, you will undergo a final evaluation to assess your overall health and the effects of the treatment. The study team will discuss the results with you and provide any necessary follow-up care or recommendations.

Who Can Join the Study?

  • Participants must be at least 18 years old.
  • Participants must have a confirmed diagnosis of follicular lymphoma (FL) or marginal zone lymphoma (MZL). MZL can be nodal, splenic, or extranodal.
  • Participants must have been treated before with at least one type of systemic anti-CD20 immunotherapy or chemo-immunotherapy. This includes treatments like rituximab alone or chemotherapy combined with immunotherapy such as rituximab or obinutuzumab, with or without additional maintenance therapy.
  • Participants must have documented relapsed, refractory, or progressive disease after treatment with systemic therapy:
    • Relapsed lymphoma: The disease returned after an initial response of complete or partial remission that lasted at least 6 months after previous therapy.
    • Refractory lymphoma: The disease did not respond well to the last treatment or the response lasted less than 6 months.
    • Progressive lymphoma: The disease worsened after an initial response of stable disease to previous therapy.

Who Cannot Join the Study?

  • Patients with other types of cancer that are not follicular lymphoma (FL) or marginal zone lymphoma (MZL) cannot participate.
  • Patients who have not experienced a return or worsening of their lymphoma after treatment, known as relapsed/refractory (R/R), are not eligible.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which may include those unable to give informed consent, are not eligible.
  • Patients who are not able to take the study medications safely cannot participate.
  • Patients with certain medical conditions that could interfere with the study treatment or outcomes are not eligible.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Hopitaux Universitaires Pitie Salpetriere Paris France
University Of Debrecen Debrecen Hungary
Laiko General Hospital Of Athens Athens Greece
Hospital Vall d’Hebron Barcelona Spain
University Hospital Ostrava Ostrava Czechia
Virgen del Rocío University Hospital Sevilla Spain
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Medical University Of Vienna Vienna Austria
Amsterdam UMC Amsterdam The Netherlands
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Helsinki University Central Hospital Helsinki Finland
Centre Hospitalier Regional Universitaire De Tours Tours France
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Turku University Hospital Turku Finland
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse Vienna Austria
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hospital Universitario De Salamanca Salamanca Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Azienda Ospedaliera Universitaria Citta’ Della Salute E Della Scienza Di Torino Turin Italy
Universitaetsklinikum Muenster AöR Munster Germany
Aalborg University Hospital Aalborg Denmark
Kepler Universitaetsklinikum GmbH Linz Austria
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
General University Hospital Of Patras Patras Greece
Centre Hospitalier Universitaire De Nantes Nantes France
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
University Of Szeged Szeged Hungary
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Hospital De La Santa Creu I Sant Pau Barcelona Spain
Medizinische Universitaet Innsbruck Innsbruck Austria
Universitaetsklinikum Essen AöR Essen Germany
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre hospitalier universitaire de Liege Liege Belgium
Katholieke Universiteit te Leuven Leuven Belgium
Oslo Universitetssykehus HF Oslo Norway
Universitair Ziekenhuis Gent Gent Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario Marques De Valdecilla Santander Spain
Hospital Del Mar Barcelona Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Institut Catala D’oncologia L'hospitalet De Llobregat Spain
Universita Degli Studi Di Brescia Brescia Italy
Centre Hospitalier Regional D’Angers Angers France
Algemeen Ziekenhuis Delta Roeselare Belgium
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi Lodz Poland
Oulu University Hospital Oulu Finland
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hospital Universitario Virgen De La Victoria Malaga Spain
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Orszagos Onkologiai Intezet Budapest Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello Palermo Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Centre Hospitalier Universitaire De Dijon Dijon France
Assistance Publique Hopitaux De Paris Paris France
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Hospital Universitario Araba Vitoria Spain
Hospital Universitario Donostia Donostia / San Sebastian Spain
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria Alexandria Italy
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
Medical Center Haaglanden Leidschendam The Netherlands
Hopital NOVO Pontoise France
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain
Azienda USL IRCCS Di Reggio Emilia Reggio Emilia Italy
Azienda Unita Sanitaria Locale Di Piacenza Piacenza Italy
Rijnstate Ziekenhuis Stichting Arnhem The Netherlands
Kuopio University Hospital Kuopio Finland
Hospital Santa Maria Della Misericordia Perugia Italy
St. Olavs Hospital HF Trondheim Norway
Instytut Hematologii I Transfuzjologii Warsaw Poland
Area De Salud De Burgos Y Soria Burgos Spain
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Uppsala University Hospital Uppsala Sweden
Tampere University Hospital Tampere Finland
Medical University Of Graz Graz Austria
Universitaetsklinikum Wuerzburg AöR Wuerzburg Germany

Other Sites

Site Name City Country Status
Hospital Son Llatzer Palma Spain
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Semmelweis University Budapest Hungary
Cuukbr Hfffyfrhxrc Yvcs Lj Fgxh Saint-Brieuc France
Onqoxjhm Vdyo Fwueb Llene Lecce Italy
Iqpvxvrz Jtakb Bproyh Brussels Belgium
Cji dfgmoqmjknudzz Epagny Metz Tessy France
Ajrdmnm Szv z oeel Poznan Poland
Omkkgnfe Sq Emkinid Rome Italy
Ufe Mffxjrgtajjz Yvoir Belgium
2rt Ary Fpfak Gukgwak Hevqpbjn Athens Greece
Abjwpgd Ohvplafgayf S Mgtgh Dj Tduod Terni Italy
Vbqwvegf Nplgiucu fuaw Gwyrphnwso Gscr Berlin Germany
Avjapcy Sbpxtycsj Umlhfmzyqvgml Gqwhoxmn Iiusvobt Trieste Italy
Hmu Zrrxocndqgesrojle Anhkyipuw Antwerp Belgium
Mlodorh Cxusmkk Lhlcwtkzkh Byry Leeuwarden The Netherlands
Vgnibnhqv Flzdhleo Nrfmupgbe V Pmago Prague Czechia
Ahoeftu Uzwxw Ssxfmxnfh Lucgfh Dhfhw Rhyhdmn Rimini Italy
Auhleks Uxwml Ssfvhfjap Lkvfpa Dzspc Rsfrcri Ravenna Italy
Ptjukm Swzm 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
15.01.2021
Belgium Belgium
Not recruiting
15.01.2021
Czechia Czechia
Not recruiting
15.01.2021
Denmark Denmark
Not recruiting
15.01.2021
Finland Finland
Not recruiting
15.01.2021
France France
Not recruiting
15.01.2021
Germany Germany
Not recruiting
15.01.2021
Greece Greece
Not recruiting
15.01.2021
Hungary Hungary
Not recruiting
15.01.2021
Ireland Ireland
Not recruiting
15.01.2021
Italy Italy
Not recruiting
15.01.2021
Norway Norway
Not recruiting
15.01.2021
Poland Poland
Not recruiting
15.01.2021
Spain Spain
Not recruiting
15.01.2021
Sweden Sweden
Not recruiting
15.01.2021
The Netherlands The Netherlands
Not recruiting
15.01.2021

Trial locations

Tafasitamab is a type of medication that helps the immune system find and destroy cancer cells. It works by attaching to a specific protein found on the surface of certain cancer cells, making it easier for the body’s natural defenses to target and eliminate them. In this trial, tafasitamab is being tested to see if it can help treat certain types of lymphoma, which is a cancer of the lymphatic system.

Lenalidomide is a medication that helps the immune system fight cancer. It works by affecting the way the immune system functions, which can help slow down or stop the growth of cancer cells. Lenalidomide is used in this trial to see if it can improve the treatment of lymphoma when used with other medications.

Rituximab is a medication that targets specific cells in the immune system. It works by attaching to a protein on the surface of certain white blood cells, which can help destroy these cells when they are cancerous. Rituximab is commonly used to treat different types of lymphoma, and in this trial, it is being used to see if it can enhance the effectiveness of other treatments for lymphoma.

Follicular Lymphoma – Follicular lymphoma is a type of non-Hodgkin lymphoma that originates from B-lymphocytes, a kind of white blood cell. It typically progresses slowly and is characterized by the formation of tumors in the lymph nodes. Over time, it can spread to other parts of the body, including the bone marrow and spleen. The disease often presents with painless swelling of lymph nodes, fatigue, and sometimes fever or night sweats. As it advances, it may lead to more significant symptoms due to the involvement of multiple lymph nodes and organs. The progression can vary, with periods of stability followed by more active phases.

Marginal Zone Lymphoma – Marginal zone lymphoma is a type of non-Hodgkin lymphoma that arises from B-cells in the marginal zone of lymphoid tissue. It generally progresses slowly and can occur in various forms, including extranodal, nodal, and splenic types. The disease often presents with symptoms such as swollen lymph nodes, fatigue, and sometimes abdominal discomfort if the spleen is involved. It can spread to other lymphoid tissues and organs over time. The progression is typically indolent, with long periods of minimal symptoms. However, it can transform into a more aggressive form of lymphoma in some cases.

Trial ID:
2023-504684-16-00
Protocol code:
INCMOR0208-301
Trial Phase:
Therapeutic confirmatory (Phase III)

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