A study evaluating glofitamab and a drug combination for patients with relapsed or refractory diffuse large B-cell lymphoma.

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What is this study about?

This study focuses on Diffuse Large B-cell Lymphoma, which is a type of blood cancer that affects white blood cells. The research is specifically for individuals whose cancer has Relapsed or refractory, meaning the cancer has returned after treatment or has stopped responding to initial therapies. The purpose of the study is to compare the effectiveness of a new treatment combination against a standard treatment combination.

Participants in the study will receive one of two different treatment paths. One group will receive glofitamab along with gemcitabine and oxaliplatin. The other group will receive rituximab combined with gemcitabine and oxaliplatin. These medications are administered through an IV infusion, which is a method where medicine is delivered directly into a vein using a needle or a small tube.

During the course of the study, the health and response to the treatments will be monitored. The study will track how long patients live and how long they live without the disease getting worse. Researchers will also look for side effects, such as cytokine-release syndrome, which is a temporary reaction where the body’s immune system becomes overly active. The study involves regular check-ups to observe how the medications affect the body and the cancer.

Who Can Join the Study?

  • You must be expected to live for at least 12 weeks.
  • A doctor must confirm through a tissue sample that you have diffuse large B-cell lymphoma, not otherwise specified (NOS), which is a specific type of blood cancer.
  • Your cancer must be relapsed, meaning it has come back after treatment, or refractory, meaning it has not responded to treatment.
  • You must have received at least one previous round of systemic therapy, which is medicine that travels through your entire body to treat the cancer.
  • If you have only tried one previous treatment, you must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant, which is a process involving very strong medicine and then using your own stored cells to rebuild your immune system.
  • A computed tomography (CT) scan, which is a detailed X-ray image of the inside of your body, must show at least one nodal lesion (a tumor in a lymph node) that is at least 1.5 cm wide, or one extranodal lesion (a tumor located outside of a lymph node) that is at least 1 cm wide.

Who Cannot Join the Study?

  • You have only failed one previous type of treatment and are a candidate for a stem cell transplantation, which is a procedure where healthy blood-forming cells are put into your body to replace damaged ones.
  • You cannot take the specific medicines used in this study, such as obinutuzumab, rituximab, gemcitabine, oxaliplatin, or tocilizumab, due to medical reasons.
  • You have a history where a slow-growing cancer, known as indolent disease, changed into a fast-growing cancer called diffuse large B-cell lymphoma (DLBCL).
  • You have a specific type of fast-growing cancer called high-grade B-cell lymphoma that involves changes to certain genes, such as MYC, BCL2, or BCL6, or is classified as NOS (not otherwise specified) under the 2016 medical guidelines.
  • You have primary mediastinal B-cell lymphoma, which is a type of cancer that starts in the area of the chest between the lungs.
  • You have a history of severe allergic or anaphylactic reactions, which are extreme and dangerous allergic responses, to certain types of laboratory-made proteins called humanized or murine monoclonal antibodies or if you are allergic to products made from mice.

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 hospitalier universitaire de Liege Liege Belgium
Instytut Hematologii I Transfuzjologii Warsaw Poland
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie Olsztyn Poland
Hospital Clinico Universitario De Valencia Valencia Spain
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Regensburg AöR Regensburg Germany
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Rigshospitalet Copenhagen Denmark
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Igkpzomy Bohejjwf Bordeaux France
Akxjig Ucjxasfzfy Huctguei Aarhus Denmark
Uyyladieepgotj Cayhksn Kpgorgmii Gdansk Poland

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
29.04.2021
Denmark Denmark
Not recruiting
29.04.2021
France France
Not recruiting
29.04.2021
Germany Germany
Not recruiting
29.04.2021
Poland Poland
Not recruiting
29.04.2021
Spain Spain
Not recruiting
29.04.2021

Trial locations

Rituximab is a medication used in this study to target and help destroy specific immune cells that are involved in certain types of cancer.

Glofitamab is a therapy used in this study that works by helping the body’s own immune system recognize and attack cancer cells.

Gemcitabine and Oxaliplatin are chemotherapy drugs used in this study to stop the growth of cancer cells.

Relapsed or refractory diffuse large B-cell lymphoma – This is a type of blood cancer that starts in the B cells, which are a specific kind of white blood cell. The disease is characterized by the rapid growth of large, abnormal B cells in the lymph nodes and other parts of the body. It is considered relapsed when the cancer returns after a period of improvement or disappearance. It is considered refractory when the cancer does not respond to the initial treatment. As the condition progresses, the abnormal cells continue to multiply and spread through the lymphatic system.

Trial ID:
2023-506899-27-00
Protocol code:
GO41944
Trial Phase:
Therapeutic confirmatory (Phase III)

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  • Study to Optimize Cytokine Release Syndrome for Glofitamab with Gemcitabine and Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma

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