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

2 1 1 1

What is this study about?

This clinical trial is focused on studying a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL), which is a condition where the body produces abnormal B-cells, a type of white blood cell. The study is specifically for patients whose DLBCL has returned or has not responded to previous treatments. The trial will explore the effects of a new treatment combination that includes the medications Glofitamab, Gemcitabine, and Oxaliplatin. Glofitamab is a type of protein-based medication, while Gemcitabine and Oxaliplatin are chemotherapy drugs that help stop the growth of cancer cells.

The purpose of the study is to understand how this combination of medications affects a condition known as Cytokine Release Syndrome (CRS), which can occur when the immune system reacts strongly to certain treatments. The study will monitor how often CRS happens and how severe it is when patients receive the treatment. Patients will receive the medications through an intravenous (IV) infusion, which means the drugs are given directly into the bloodstream through a vein. The study will also look at how well patients tolerate the treatment and any side effects they might experience.

Participants in the study will receive the treatment over a period of time, with regular check-ups to monitor their health and the effects of the treatment. The study aims to provide valuable information on the safety and effectiveness of this treatment combination for patients with relapsed or refractory DLBCL. The trial is expected to continue for several years, allowing researchers to gather comprehensive data on the treatment’s impact on patients’ health and quality of life.

1 initial assessment

The initial assessment involves confirming eligibility based on specific criteria such as life expectancy of at least 12 weeks and a confirmed diagnosis of relapsed or refractory diffuse large B-cell lymphoma.

A comprehensive review of medical history and previous treatments is conducted to ensure suitability for the study.

2 treatment initiation

Treatment begins with the administration of medications through IV infusion. The medications include oxaliplatin, gemcitabine, glofitamab, and obinutuzumab.

The specific dosages and frequency of administration are determined by the study protocol and are tailored to each participant’s needs.

3 monitoring and evaluation

Regular monitoring is conducted to evaluate the response to treatment and to identify any side effects. This includes assessing the incidence of cytokine release syndrome (CRS) and other adverse events.

The severity of any side effects is graded according to established criteria, and adjustments to the treatment plan may be made as necessary.

4 follow-up assessments

Follow-up assessments are scheduled to track the progress of the disease and the effectiveness of the treatment.

These assessments include imaging studies to measure the size of any remaining lymphoma lesions and to determine the overall response to the treatment.

5 completion of study participation

Upon completion of the study, a final evaluation is conducted to assess the overall outcomes, including the duration of response and survival rates.

Participants are provided with a summary of their treatment and any recommendations for future care.

Who Can Join the Study?

  • Participants must have a life expectancy of at least 12 weeks.
  • Participants must have a confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), which is a type of cancer that affects certain white blood cells.
  • The disease must have returned or not responded to previous treatments, known as relapsed/refractory disease.
  • Participants must have received at least one previous treatment that affects the whole body, known as systemic therapy. Local treatments like radiation do not count as systemic therapy.
  • If participants have only had one previous treatment, they must not be suitable for a high-dose chemotherapy followed by a procedure called autologous stem cell transplant (ASCT), which is a treatment that uses the patient’s own stem cells.
  • Participants must have at least one lymph node that can be measured in two directions and is larger than 1.5 cm, or one area outside the lymph nodes that can be measured in two directions and is larger than 1 cm, as seen on a CT scan, which is a type of detailed imaging test.
  • Participants can be of any gender.
  • The study includes vulnerable populations, which means it may include people who are at greater risk of harm or exploitation.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Rennes Rennes France
Universita Degli Studi Di Brescia Brescia Italy
Ugmnqfldwy Hfhetgjn Culeiur Cologne Germany
Iguicsmw Rokunzrdb Pqi Lu Sebvof Dov Tfymxs Djcn Alzapmp Iwph Sbjhrx Meldola Italy
Csuako Hwpcokrkczc Rrjfpmkx Ugmnefidenuks Do Tcocv Tours France

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

Trial status

Country Status Recruitment Start
France France
Recruiting
01.04.2025
Germany Germany
Not recruiting
01.04.2025
Italy Italy
Recruiting
01.04.2025

Trial locations

Glofitamab is a medication being studied for its potential to help treat patients with a type of cancer called diffuse large B-cell lymphoma, especially when the cancer has returned or not responded to previous treatments. It is being tested to see how it works in combination with other cancer-fighting drugs.

Gemcitabine is a chemotherapy drug used to treat various types of cancer. In this study, it is combined with other medications to see if it can help improve outcomes for patients with diffuse large B-cell lymphoma.

Oxaliplatin is another chemotherapy medication that is often used to treat cancer. It is being used in this study alongside other drugs to determine if it can help manage or reduce the symptoms of diffuse large B-cell lymphoma.

Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs. The disease can develop in any part of the body and often presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. DLBCL is known for its aggressive nature, meaning it can progress quickly if not managed. It is the most common subtype of non-Hodgkin lymphoma and can occur at any age, though it is more prevalent in older adults. The progression of the disease can vary, with some cases responding well to treatment while others may be more challenging to manage.

Trial ID:
2024-516791-15-00
Protocol code:
GO45434
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies

    Recruiting

    1 1 1 1
    Germany Italy Poland
  • Study on the Effectiveness and Safety of AZD0486 for Adults with Relapsed or Refractory Non-Hodgkin Lymphoma

    Recruiting

    2 1 1
    Denmark France Germany Italy Spain Sweden