What side effects are associated with this type of intervention?

Common side effects of treatments for Non-Hodgkin's Lymphoma, particularly those involving bispecific antibodies like Glofitamab and combination therapies with rituximab, include cytokine release syndrome (CRS) with symptoms such as fever, nausea, headache, hypotension, and tachycardia. Rituximab is associated with infusion reactions, including fever, chills, rash, and severe respiratory symptoms. Combination therapies with chemotherapeutic agents like ifosfamide, carboplatin, and etoposide (R-ICE) can cause myelosuppression, leading to increased risk of infections, anemia, and thrombocytopenia, as well as nausea, vomiting, alopecia, and peripheral neuropathy.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma (NHL) that are similar to Glofitamab. Rituximab, a monoclonal antibody targeting CD20, was one of the first and most significant approvals for NHL. More recently, bispecific antibodies like Blinatumomab, which targets CD19 and CD3, have been approved for certain types of NHL. Additionally, combination therapies involving rituximab and chemotherapy agents such as ifosfamide, carboplatin, and etoposide (R-ICE) have been used in relapsed or refractory cases. These treatments aim to leverage the immune system to target and destroy lymphoma cells, similar to the mechanism of action of Glofitamab.

What other types of research exist?

Promising novel alternatives to Glofitamab for Non-Hodgkin's Lymphoma patients include: 1) CAR-T cell therapies such as Axicabtagene Ciloleucel (Yescarta) and Tisagenlecleucel (Kymriah), which have shown significant efficacy in relapsed/refractory NHL. 2) Bispecific T-cell engagers (BiTEs) like Blinatumomab, which targets CD19 and CD3. 3) Antibody-drug conjugates (ADCs) such as Polatuzumab Vedotin, which targets CD79b. 4) Novel monoclonal antibodies like Tafasitamab, which targets CD19. These therapies offer different mechanisms of action and have demonstrated promising results in clinical settings.

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Alkylating agents

Glofitamab + Chemotherapy for Non-Hodgkin's Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be a candidate for high-dose chemotherapy followed by ASCT or CAR-T therapy

Histologically confirmed B-cell lymphoma

Must not have

Prior allogeneic stem cell transplant

Prior autologous stem cell transplant for any indication other than lymphoma, within 5 years from the start of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called glofitamab combined with other cancer drugs in patients with a type of lymphoma that hasn't responded to previous treatments. The treatment works by helping the immune system attack cancer cells and using chemotherapy to kill or stop the growth of these cells.

Who is the study for?

This trial is for people with a type of cancer called diffuse large B-cell lymphoma that has come back or didn't respond after their first treatment. They must have had therapy before that included an anti-CD20 antibody and anthracycline, be healthy enough to consider more intense treatments like stem cell transplant or CAR-T therapy, and not have certain medical conditions.

What is being tested?

Researchers are testing how well Glofitamab works when given with Rituximab plus Ifosfamide, Carboplatin, and Etoposide in patients whose cancer returned or resisted the first line of treatment. The study will look at the drug's effects on the body and its safety.

What are the potential side effects?

Possible side effects include reactions related to infusion of these drugs, blood disorders, increased risk of infections due to weakened immune system, organ inflammation from immune responses, fatigue, nausea, neuropathy (nerve problems), and liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for intense chemotherapy followed by stem cell or CAR-T therapy.

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My cancer is a type of B-cell lymphoma confirmed by lab tests.

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I am fully active or can carry out light work.

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My cancer came back or didn't respond after my first chemoimmunotherapy.

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I have had one treatment that included rituximab and an anthracycline.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stem cell transplant from a donor.

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I had a stem cell transplant for a condition other than lymphoma within the last 5 years.

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I am currently being treated for an autoimmune disease.

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I have or had a brain-related condition like stroke or epilepsy.

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I have been diagnosed with progressive multifocal leukoencephalopathy.

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My nerve damage is not severe.

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I have or might have had HLH.

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I have been treated with glofitamab or similar drugs.

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I have or had lymphoma in my brain or spinal cord.

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I have had more than one treatment for diffuse large B-cell lymphoma.

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I have been diagnosed with primary mediastinal B-cell lymphoma.

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I have had a stem cell transplant for lymphoma.

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I have a significant history of liver disease.

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I have had a solid organ transplant.

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I haven't taken any immune-weakening medications in the last 4 weeks.

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I haven't had cancer treatments like chemo or immunotherapy in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Mobilization-adjusted response rate (MARR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: R/R DLBCLExperimental Treatment7 Interventions

Participants will receive up to 3 21-day cycles of glofitamab, rituximab, ifosfamide, carboplatin, and etoposide (glofit-R-ICE).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glofitamab

2021

Completed Phase 1

~60

Obinutuzumab

2014

Completed Phase 3

~3470

Tocilizumab

2012

Completed Phase 4

~1840

Rituximab

1999

Completed Phase 4

~2990

Ifosfamide

2010

Completed Phase 4

~3350

Carboplatin

2014

Completed Phase 3

~6120

Etoposide

2010

Completed Phase 3

~2960

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include monoclonal antibodies, chemotherapy, and newer immunotherapies like bispecific antibodies. Monoclonal antibodies, such as rituximab, target specific proteins on the surface of lymphoma cells (e.g., CD20), marking them for destruction by the immune system. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Bispecific antibodies, like Glofitamab, simultaneously bind to CD20 on lymphoma cells and CD3 on T-cells, bringing them into close proximity to induce T-cell mediated cytotoxicity. This dual-targeting mechanism is significant for NHL patients as it harnesses the body's immune system to specifically target and kill cancer cells, potentially leading to more effective and targeted treatment outcomes.