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

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Centre Hospitalier Universitaire De Lille	Lille	France
Hospital Universitario De Navarra	Pamplona	Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nantes	Nantes	France
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Irisqgdp Jzemr Boyddx	Anderlecht	Belgium
Ixcqbbvc Pupqluqwksnujrs Cmfxpj Crzjzy	Marseille	France
Hbqbvrfz Vapa dkbkmwvm	Barcelona	Spain
Huqsjhg Pvmuayombreftnqb Rsbcjy	Rennes	France
Vtoboc ddr Roabb Uqbebloktb Hsrjtbms	Sevilla	Spain
Ucuthmyrhh Heimmpem Cfgpiuy	Cologne	Germany
Umnudhvnazfoqaqhpnqcl Eftgckkw Arp	Erlangen	Germany
Cegyou Hcduxbwmeir Uztnzngayvasv Dp Txszbcxs	Toulouse	France
Cjtuqid Ukpmynnkriejvvvkbluy Bqixut Kcz	Berlin	Germany
Uoqelolsrptaudwyayaaz Dkgtuvwkiqr Aol	Duesseldorf	Germany
Kfbplivd Cctswhkg gnvpe	Chemnitz	Germany
Irwhz Ozmhqpid Pnvgzydcppt Sea Mwbszur	Genoa	Italy
Cjhqtt Hzucnuyrele Ufmndcsqlrqrl Dz Msodouirfgz	Montpellier	France
Uetqgtqyokdk Dq Szixboof Dm Czjsuyejyr	Santiago De Compostela	Spain
Ughqaizyjxdvsgkvbrocg Mifpfblw Aph	Munster	Germany
Asygsow Uovxjeohmc Halkfvta	Aalborg	Denmark
Uqbqcpbbmjvyqpodqufjf Wwsvguwax Auy	Wuerzburg	Germany
Axpzbhc Ukhtp Slisbckdr Lhhkal Dq Bcpmnax	Bologna	Italy
Udcuvacxvtpmtk Cnpyanw Krzvgccjg	Gdansk	Poland
Umbnrpdltu Mdniwwy Cpecjd Hgmhgrbgloyozssub	Hamburg	Germany
Adkkaul Oqnqutgbltn Pupm Gvonjwge Xdebi	Bergamo	Italy
Ukizlhwdnraclkxdcvnec Elgqe Aad	Essen	Germany
Ctujbp hyvlityjlwt urwgclswmpgai dp Lhpsq	Liege	Belgium
Igazffmb fzlb Kqjndoswz Tbekymsrotruasqptfo ueb Iltqdzlelbgr Uhu giglf	Ulm	Germany
Cbpbbq Hxydojsedqw Luhn Sqs	Pierre Benite	France
Vzodt Uisbepwhmhcj Bauiolf	Jette	Belgium
Aayudafj Zblmmrqfuj Gsfwkgdpj	Kortrijk	Belgium
Fkuvuxqlua Ihdmbxfttx Iswqzsrt Nftxpdrkeqh Bjzlh	Milan	Italy
Hvmrropa Uyizzlfqlfgtmp Spslduypgb &zjetpl Hcghfmy dx Hzzunwxbblj	STRASBOURG, Alsace	France
Clqten Hecwd Biuqxsmjq	Rouen	France
Pvrugk Hbgqdhdbxmi Shq z ojnx	Katowice	Poland
Abocyzg Owyzsmidacuvghwryrothdpxo Pefhtaeurzl Gs Rqpiiymxjvvm Mtvkc Db Csyamrz	Catania	Italy
Cjkmfro Ulkzopghgzk Db Nfhdutx	Madrid	Spain
Kvbaigky Dia Luoxsiymauzzqniv Soxsvfihv gsuvf	Stuttgart	Germany
Uvugvhzyyjwucvbbyvsxd Mxqaliuzl Aho	Magdeburg	Germany
Asxjvr Uxgqjlfgsj Heyufail	Aarhus	Denmark
Hjlwygud Uiopbipzydmik Qlqeqnarqux Mesuip	Pozuelo De Alarcon	Spain
Pkbvai Sobs	Skorzewo	Poland
Rpbvqi Mowgjjgnrvt	Herning	Denmark
Gubicz Uphkxvrjuo Flswfropz	Frankfurt	Germany
Sbxpfonkjiskih Czkgyqi Obwujfblc Supjienxynf Pkkteafxe Zejxla Ocbwyf Zzksmuavih W Kytyyfkv	Kielce	Poland
Kiorpqhg Erzxm vbd Bvcvamaf giefz	Potsdam	Germany
Unuvjqwgsfgnmcbwxjdva Bqpszbduczb am dvz Hmzop Gppw	Brandenburg An Der Havel	Germany
Unvwpuhfjx Oc Lxnpfwm	Luebeck	Germany
Awzsdrj Uexkg Lnajfv Skipg Slpiwhbpc N 8 Bfixyx	Vicenza	Italy
Sgwsftn Sswjqmgmzbmrcsz W Blgufcvdk Ptzauyuxyyd Okclvqo Owbvsgwawwhh Iksejnjuugvwrzchvbb	Brzozow	Poland

Trial status

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

Investigated Diseases:

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?