What side effects are associated with this type of intervention?

Common treatments for Diffuse Large B-Cell Lymphoma (DLBCL) include chemotherapy regimens such as R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) and newer therapies like bispecific antibodies (e.g., glofitamab). Side effects of these treatments can include infusion reactions, cytopenias (low blood cell counts), infections, fatigue, nausea, and neuropathy. Specifically, bispecific antibodies like glofitamab may cause cytokine release syndrome (CRS), which can lead to fever, hypotension, and hypoxia. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Diffuse Large B-Cell Lymphoma (DLBCL), particularly those targeting CD20 on B-cells. Rituximab, a monoclonal antibody targeting CD20, has been a cornerstone in DLBCL treatment, often combined with chemotherapy regimens like CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone). More recently, other CD20-targeting agents such as Obinutuzumab and Ofatumumab have been approved. Additionally, bispecific antibodies like Blinatumomab, which targets CD19 on B-cells and CD3 on T-cells, have shown promise in similar B-cell malignancies, although not specifically for DLBCL. Glofitamab, currently under investigation, represents a novel approach by targeting both CD20 and CD3, potentially offering a new therapeutic option for relapsed or refractory DLBCL.

What other types of research exist?

Promising novel alternatives to Glofitamab for DLBCL patients include: 1) Polatuzumab vedotin (an antibody-drug conjugate targeting CD79b), 2) Loncastuximab tesirine (an antibody-drug conjugate targeting CD19), 3) CAR T-cell therapies such as Axicabtagene ciloleucel and Tisagenlecleucel, and 4) Bispecific antibodies like Mosunetuzumab (targeting CD20 and CD3). These therapies have shown significant efficacy in clinical trials and are expected to be key options for DLBCL treatment in the near future.

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Alkylating agents

Glofitamab Combo vs Rituximab Combo for Diffuse Large B-Cell Lymphoma

Phase 3

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

Relapsed/refractory (R/R) disease, defined as follows: Relapsed = disease that has recurred ≥6 months after completion of the last line of therapy; Refractory = disease that either progressed during the last line of therapy or progressed within 6 months (<6 months) of the last line of prior therapy

At least one bi-dimensionally measurable (≥1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥1 cm) extranodal lesion, as measured on computed tomography (CT) scan

Must not have

Known or suspected chronic active Epstein-Barr viral infection

Primary mediastinal B-cell lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new treatment for patients with a type of lymphoma that has come back or didn't respond to previous treatments. The treatment combines glofitamab, which helps the immune system attack cancer, with two chemotherapy drugs that kill cancer cells.

Who is the study for?

This trial is for adults with relapsed/refractory diffuse large B-cell lymphoma who have had at least one prior systemic therapy and are not candidates for stem cell transplant. Participants must have measurable disease, be in stable condition (ECOG 0-2), have adequate organ function, and a recent negative COVID-19 test.

What is being tested?

The study compares the effectiveness of two treatments: Glofitamab combined with Gemcitabine + Oxaliplatin versus Rituximab with the same chemotherapy drugs. It aims to determine which combination is more effective for patients who haven't responded well to previous therapies.

What are the potential side effects?

Potential side effects include allergic reactions to treatment components, nerve damage (peripheral neuropathy), infections due to weakened immune systems, and general side effects from chemotherapy like nausea, fatigue, or hair loss.

Eligibility Criteria

Inclusion Criteria

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

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My disease came back or didn't respond to treatment within 6 months of my last therapy.

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I have a tumor that can be measured on a CT scan.

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My diagnosis is diffuse large B-cell lymphoma.

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I can take care of myself and am up and about more than half of my waking hours.

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My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.

Exclusion Criteria

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

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I have or might have a long-term Epstein-Barr virus infection.

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My condition is primary mediastinal B-cell lymphoma.

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I cannot take obinutuzumab, rituximab, gemcitabine, oxaliplatin, or tocilizumab due to adverse reactions.

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I haven't had cancer treatments like radiotherapy or chemotherapy in the last 2 weeks.

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My lymphoma is high-grade with specific genetic changes.

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I tested positive for COVID-19 in the last 30 days.

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I have or might have had HLH.

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I have been diagnosed with progressive multifocal leukoencephalopathy.

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I have a significant history of liver disease.

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I have had a stem cell transplant from a donor.

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I have not been treated with glofitamab or similar drugs.

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I do not have severe nerve damage.

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I might have tuberculosis.

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My slow-growing cancer has changed into aggressive large B-cell lymphoma.

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

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I have not received a live vaccine in the last 4 weeks and do not plan to during the study.

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

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

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I have had a solid organ transplant.

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I am currently being treated for an autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2021 Phase 1 trial • 23 Patients • NCT04313608

41%

Cytokine release syndrome

35%

Anaemia

35%

Diarrhoea

35%

Hypomagnesaemia

35%

Pyrexia

35%

Neuropathy peripheral

24%

Platelet count decreased

24%

Fatigue

24%

Neutropenia

24%

Hypophosphataemia

24%

Nausea

24%

Liver function test abnormal

24%

Constipation

24%

Thrombocytopenia

18%

Oral candidiasis

18%

Lethargy

18%

Arthralgia

18%

Weight decreased

18%

Neutrophil count decreased

18%

Hypokalaemia

18%

Sepsis

18%

Headache

18%

Peripheral sensory neuropathy

12%

Paraesthesia

12%

Vomiting

12%

Superficial vein thrombosis

12%

Rectal haemorrhage

12%

Flushing

12%

Infusion related reaction

12%

Alanine aminotransferase increased

12%

Cough

12%

Blood alkaline phosphatase increased

12%

Abdominal pain

12%

Pain in extremity

12%

Gastrooesophageal reflux disease

12%

Colitis

12%

Abdominal discomfort

12%

Dizziness

Photosensitivity reaction

Adenocarcinoma

Dyspnoea exertional

Wound infection

Chest pain

Gamma-glutamyltransferase increased

Orthostatic hypotension

Cellulitis

Hypogammaglobulinaemia

External ear cellulitis

Tumour lysis syndrome

Vasospasm

Upper respiratory tract infection

Abdominal distension

Urinary tract infection

Transient ischaemic attack

Hypertension

Blood creatinine increased

Abdominal tenderness

Seasonal allergy

Injury

Hypoalbuminaemia

Performance status decreased

Hyperlipidaemia

Hyperglycaemia

Epistaxis

Oropharyngeal pain

Intention tremor

Hypocalcaemia

Decreased appetite

Back pain

Throat irritation

Rash

Thrombosis

Rash maculo-papular

Cytomegalovirus infection reactivation

Squamous cell carcinoma

Depression

Neutropenic sepsis

Vision blurred

Abdominal pain lower

Anal haemorrhage

Aspartate aminotransferase increased

Groin pain

Pain in jaw

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Glofit-GemOx

Arm B: Mosun-GemOx

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: R-GemOxExperimental Treatment3 Interventions

Participants will receive rituxumab (R) in combination with gemcitabine and oxaliplatin (GemOx) for up to 8 cycles. Treatment is administered in 21-day cycles.

Group II: Glofit-GemOxExperimental Treatment5 Interventions

Participants will receive up to 8 cycles of glofitamab (Glofit) in combination with gemcitabine and oxaliplatin (GemOx), followed by up to 4 cycles of glofitamab monotherapy. A single dose of obinutuzumab will be administered 7 days prior to the first dose of glofitamab. Treatment is administered in 21-day cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glofitamab

2021

Completed Phase 1

~60

Rituxumab

2019

Completed Phase 2

~120

Gemcitabine

2017

Completed Phase 3

~1920

Obinutuzumab

2014

Completed Phase 3

~3470

Oxaliplatin

2011

Completed Phase 4

~2890

Tocilizumab

2012

Completed Phase 4

~1840

0 / 25Eligibility 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

Common treatments for Diffuse Large B-Cell Lymphoma (DLBCL) include targeted therapies and chemotherapy. Glofitamab, a bispecific antibody, targets CD20 on B-cells and CD3 on T-cells, facilitating the immune system's ability to destroy cancer cells. Rituximab, another anti-CD20 monoclonal antibody, also targets B-cells for immune-mediated destruction. Chemotherapy agents like gemcitabine and oxaliplatin disrupt DNA replication and cell division, leading to cancer cell death. These mechanisms are important for DLBCL patients as they offer targeted approaches to effectively eliminate cancer cells while aiming to reduce harm to normal cells.