Study on the Effectiveness and Safety of Glofitamab with Drug Combination for Untreated Large B-Cell Lymphoma Patients

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What is this study about?

This clinical trial is focused on studying a type of cancer called Large B-Cell Lymphoma, which is a form of non-Hodgkin lymphoma affecting the B-cells in the immune system. The study aims to compare the effectiveness and safety of a new treatment combination. This combination includes the drugs Glofitamab and Polatuzumab Vedotin, along with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone. These medications are used to target and destroy cancer cells, and they work in different ways to help treat the lymphoma.

The purpose of the study is to evaluate how well the combination of Glofitamab with the other drugs works compared to the standard treatment, which includes Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone. Participants in the study will receive one of these treatment combinations. The study will monitor the participants over a period to see how the cancer responds to the treatment and to check for any side effects. The study will also look at how long participants live without the cancer getting worse, which is known as progression-free survival.

Participants will be closely monitored throughout the study, which will include regular check-ups and tests to assess their health and the effectiveness of the treatment. The study is designed to provide valuable information on whether the new combination of drugs can offer better outcomes for patients with Large B-Cell Lymphoma compared to the existing standard treatment. This research could potentially lead to improved treatment options for individuals diagnosed with this type of lymphoma.

1 initial assessment

Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes providing a sample of tumor tissue, either from previous tests or a new collection.

Your overall health will be evaluated, including a performance status check and blood tests to ensure adequate hematologic function.

2 treatment phase

You will receive a combination of medications designed to treat large B-cell lymphoma. The main treatment involves **glofitamab** in combination with **polatuzumab vedotin**, **rituximab**, **cyclophosphamide**, **doxorubicin**, and **prednisone**.

These medications are administered through **intravenous infusion** at specified intervals. The exact dosage and frequency will be determined by the study protocol and your healthcare team.

3 monitoring and follow-up

Throughout the study, your health and response to treatment will be closely monitored. This includes regular check-ups, blood tests, and imaging studies to assess the progression of the lymphoma.

You may also be asked to complete questionnaires about your physical functioning and any symptoms you experience.

4 end of treatment evaluation

At the end of the treatment phase, a comprehensive evaluation will be conducted to determine the effectiveness of the therapy. This includes imaging tests and possibly a biopsy to assess the response of the lymphoma.

Your healthcare team will discuss the results with you and outline any further steps or treatments that may be necessary.

5 long-term follow-up

After completing the treatment, you will enter a long-term follow-up phase. This involves periodic visits to monitor your health and detect any potential recurrence of the lymphoma.

The follow-up period is designed to ensure your continued well-being and address any late effects of the treatment.

Who Can Join the Study?

  • Participants must have previously untreated large B-cell lymphoma, which is a type of cancer affecting the lymphatic system.
  • The cancer must be CD20-positive, meaning it has a specific protein on the surface of the cancer cells.
  • Participants need to provide a sample of their tumor tissue, which can be from a previous collection or newly collected.
  • Participants must have an IPI score between 2 and 5. The IPI score is a way to assess the risk level of the lymphoma.
  • Participants should have an ECOG Performance Status of 0, 1, or 2. This is a scale used to assess how well a person can perform daily activities. A lower score means better functioning.
  • Participants must have a life expectancy of at least 6 months.
  • Participants need to have adequate hematologic function, meaning their blood cell levels should be within a certain range.
  • Participants must have a negative HIV test at the time of screening.
  • Both male and female participants are eligible.

Who Cannot Join the Study?

  • Patients with any other type of cancer that is not Large B-Cell Lymphoma.
  • Patients who have had a different cancer treatment within the last 4 weeks.
  • Patients with severe heart problems.
  • Patients with uncontrolled infections.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had an organ transplant.
  • Patients with a history of severe allergic reactions to similar medications.
  • Patients with a condition that affects the immune system, like HIV.
  • Patients who are currently participating in another clinical trial.
  • Patients with any other medical condition that the study doctors think would make it unsafe to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Henri Becquerel Rouen France
Pratia Hematologia Sp. z o.o. Katowice Poland
Universitaetsklinikum Erlangen AöR Erlangen Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Institut Jules Bordet Anderlecht Belgium
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Virgen del Rocío University Hospital Sevilla Spain
Centre Hospitalier Universitaire De Toulouse Toulouse France
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universidade De Santiago De Compostela Santiago De Compostela Spain
Aalborg University Hospital Aalborg Denmark
Pratia S.A. Skorzewo Poland
Centre Hospitalier Universitaire De Nantes Nantes France
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Centre hospitalier universitaire de Liege Liege Belgium
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Klinikum Ernst von Bergmann gGmbH Potsdam Germany
Universitaetsklinikum Brandenburg an der Havel GmbH Brandenburg An Der Havel Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Vrije Universiteit Brussel Jette Belgium
University Of Luebeck Luebeck Germany
Azienda Unita Locale Socio Sanitaria N 8 Berica Vicenza Italy
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hôpital Pontchaillou-CHU Rennes Rennes France
Ualhisfbbm Hcsbzvwl Ctdhlgs Cologne Germany
Upuccvcslabmbimanyajc Dncymhrscep Aor Duesseldorf Germany
Aeibqn Uveoevuygb Hdzdtzar Aarhus Denmark
Upeaisdpcradmeqakveuc Mkpaylnr Azu Munster Germany
Rockrv Mysfsoyyoxw Herning Denmark
Gszvwj Utgkuixenx Fpipjuavt Frankfurt Germany
Uyzwosbdidunwokkfonmc Wwbkzilch Apg Wuerzburg Germany
Agnvhgs Uitff Scjldghdp Ltadxp Dx Bskvvmd Bologna Italy
Ubsuypbfktqevz Cikffxy Kembtbeck Gdansk Poland
Ucapnwakso Mufwvuo Cjbqul Hiepcxctylguveflf Hamburg Germany
Anwbain Oulhjyzewji Pcot Gscxinpw Xyduy Bergamo Italy
Uddcrsiqiynfqzxhhsqtu Esixt Anx Essen Germany
Hbaxgvua Vkdm dxhiytnb Barcelona Spain
Iypziedy Pundxtcrwjhqjgi Cxwuvy Czwbjq Marseille France
Hxbltmdf Uhudjctcjpfyml Svfsdpzggz &vpyetr Hdgbami dc Hrrqpeoyirr STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
15.09.2023
Denmark Denmark
Not recruiting
15.09.2023
France France
Not recruiting
15.09.2023
Germany Germany
Not recruiting
15.09.2023
Italy Italy
Not recruiting
15.09.2023
Poland Poland
Not recruiting
15.09.2023
Spain Spain
Not recruiting
15.09.2023

Trial locations

Glofitamab is a medication being studied for its potential to help treat large B-cell lymphoma, a type of cancer that affects the lymphatic system. It works by helping the body’s immune system recognize and attack cancer cells more effectively. In this trial, researchers are looking at how well glofitamab works when used together with other cancer-fighting drugs.

Polatuzumab Vedotin is a medication used in the treatment of certain types of lymphoma. It is designed to target and destroy cancer cells while sparing healthy cells. Polatuzumab vedotin is often used in combination with other medications to enhance its effectiveness in fighting cancer.

Rituximab is a medication that helps the immune system find and destroy cancer cells. It is commonly used to treat various types of lymphoma and works by targeting specific proteins on the surface of cancer cells, making it easier for the immune system to attack them.

Cyclophosphamide is a chemotherapy drug that helps stop the growth of cancer cells. It works by interfering with the DNA of the cancer cells, preventing them from multiplying. Cyclophosphamide is often used in combination with other medications to treat different types of cancer, including lymphoma.

Doxorubicin is another chemotherapy drug used to treat cancer. It works by slowing or stopping the growth of cancer cells. Doxorubicin is often part of a combination of drugs used to treat lymphoma and other cancers, helping to improve the overall effectiveness of the treatment.

Prednisone is a type of steroid that is used to help reduce inflammation and suppress the immune system. In cancer treatment, prednisone can help manage symptoms and improve the effectiveness of other cancer-fighting drugs. It is often used in combination with other medications to treat lymphoma.

Large B-Cell Lymphoma – Large B-Cell Lymphoma is a type of non-Hodgkin lymphoma that originates in the B cells, which are a type of white blood cell responsible for producing antibodies. It typically presents as a rapidly growing mass, often in the lymph nodes, spleen, liver, or other organs. The disease progresses as the abnormal B cells multiply uncontrollably, leading to the enlargement of lymph nodes and potential spread to other parts of the body. Symptoms may include swelling of lymph nodes, fever, night sweats, and weight loss. As the lymphoma advances, it can interfere with the normal function of affected organs and tissues. The progression rate can vary, with some cases advancing more quickly than others.

Trial ID:
2023-504028-24-00
Protocol code:
GO44145
Trial Phase:
Therapeutic confirmatory (Phase III)

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