211 Participants Needed

Combination Therapy for Non-Hodgkin's Lymphoma

Recruiting at 36 trial locations
RS
RS
Overseen ByReference Study ID Number: NP39488 https://forpatients.roche.com/
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking any standard anti-cancer treatments, including investigational therapies, within 4 weeks before starting the study treatment. If you are on corticosteroids, you must not exceed 25 milligrams per day of prednisone or its equivalent within 4 weeks before and during the study.

What data supports the effectiveness of the drug combination therapy for Non-Hodgkin's Lymphoma?

The research highlights that combining targeted therapies, like monoclonal antibodies, can be very effective in treating Non-Hodgkin's Lymphoma. Although specific data on the combination of Atezolizumab, Tecentriq, Glofitamab, COLUMVI, glofitamab-gxbm, Polatuzumab Vedotin, and Polivy is not provided, similar combinations with rituximab have shown significant effects, suggesting potential effectiveness.12345

Is the combination therapy for Non-Hodgkin's Lymphoma safe?

Polatuzumab vedotin, part of the combination therapy, has shown an acceptable safety profile in clinical trials for relapsed or refractory large B-cell lymphomas, with manageable side effects. The risk of immune reactions is low, and the treatment has been used safely in various settings, including after other therapies like CAR T-cell therapy.678910

What makes the combination therapy for Non-Hodgkin's Lymphoma unique?

This combination therapy is unique because it includes Glofitamab, a bispecific antibody that engages T-cells to target and destroy lymphoma cells, and Polatuzumab Vedotin, which delivers a toxic agent directly to cancer cells. This approach is different from traditional chemotherapy and aims to enhance the immune system's ability to fight the cancer.14111213

What is the purpose of this trial?

This is an open-label, single arm, multicenter, dose finding, Phase Ib study in order to assess the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) for this combination treatment and to evaluate the general safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and preliminary anti-tumor activity of this combination treatment in adult patients.This study includes an additional open-label imaging feasibility sub-study using a tracer in adult participants with relpased/refractory B-cell non-Hodgkin's lymphoma to image CD8+T-cells at baseline and after treatment with glofitamab, including pre-treatment with obinutuzumab.

Research Team

CT

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

Adults with B-cell Non-Hodgkin's Lymphoma that has come back or didn't respond to treatment, and who have no other life-prolonging therapy options. Participants must have at least one measurable lesion, be in relatively good health (ECOG 0-2), and have proper organ function. They can't join if they've had certain autoimmune diseases, lung conditions, recent cancer treatments, transplants, infections or vaccinations.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.
My liver, blood, and kidney functions are all within normal ranges.
Negative test results for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)
See 3 more

Exclusion Criteria

I do not have severe nerve damage in my hands or feet.
I have had lung conditions like pulmonary fibrosis or pneumonia, or my CT scan shows active lung inflammation.
I have had a stem cell transplant from a donor.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive Glofitamab in combination with Atezolizumab or Polatuzumab Vedotin up to the maximum tolerated dose (MTD)

12-24 weeks
Weekly visits (in-person)

Imaging Sub-study

Participants undergo PET/CT imaging to assess CD8+ T-cells at baseline and after treatment

1 cycle
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Monthly visits (in-person)

Treatment Details

Interventions

  • Atezolizumab
  • Glofitamab
  • Polatuzumab Vedotin
Trial Overview The trial is testing a combination of drugs including Glofitamab and Atezolizumab or Polatuzumab Vedotin for safety and effectiveness in treating lymphoma. It aims to find the highest dose patients can take without serious side effects (MTD) and suggests a Phase II dose (RP2D). There's also a sub-study using an imaging tracer to see how T-cells are affected by the treatment.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Polatuzumab VedotinExperimental Treatment4 Interventions
Participants will receive Glofitamab in combination with polatuzumab vedotin up to the MTD.
Group II: Imaging Sub-studyExperimental Treatment3 Interventions
Participants will undergo positive-emission tomography/computed tomography (PET/CT) at screening, followed by an "Imaging Cycle," to replace Cycle 1 of the main study. Eligible participants will have the option roll-over to the atezolizumab arm of the main study from Cycle 2 onwards.
Group III: AtezolizumabExperimental Treatment4 Interventions
Participants will receive Glofitamab in combination with Atezolizumab up to the maximum tolerated dose (MTD).

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Tecentriq for:
  • Melanoma
  • Hepatocellular carcinoma
  • Small cell lung cancer
  • Non-small cell lung cancer
  • Urothelial carcinoma
🇪🇺
Approved in European Union as Tecentriq for:
  • Melanoma
  • Hepatocellular carcinoma
  • Small cell lung cancer
  • Non-small cell lung cancer
  • Urothelial carcinoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Findings from Research

Recent advances in targeted therapies for non-Hodgkin lymphoma, particularly the anti-CD20 monoclonal antibody rituximab, are expected to significantly improve patient care by inhibiting specific disease pathways.
Combining rituximab with other agents, such as monoclonal antibodies, immunomodulatory drugs, and Bcl-2 inhibitors, shows promise for enhancing treatment efficacy, especially in patients who do not respond to rituximab alone.
Targeted therapies for non-Hodgkin lymphoma: rationally designed combinations.Martin, P., Leonard, JP.[2019]
Rituximab, an anti-CD20 antibody, has been shown to be effective in treating various B-cell lymphoid malignancies, with benefits including improved response rates and progression-free survival, based on extensive clinical data since its introduction in 1997.
The drug is generally well-tolerated, with infusion-related side effects being the most significant, and its use has expanded from treating relapsed low-grade lymphomas to first-line therapy and more aggressive forms like diffuse large B-cell lymphoma.
Rituximab and its role as maintenance therapy in non-Hodgkin lymphoma.Collins-Burow, B., Santos, ES.[2015]
In a study of 7 patients with primary cutaneous B-cell lymphoma who had relapsed after chemotherapy, the combination of intravenous rituximab and single-dose cyclophosphamide resulted in an impressive overall response rate of 85.7%, with 5 patients achieving complete remission.
The treatment was well tolerated, and after a median follow-up of 13 months, most patients remained disease-free for significant durations, indicating promising efficacy and safety for this approach in managing relapsed cases.
Systemic therapy with cyclophosphamide and anti-CD20 antibody (rituximab) in relapsed primary cutaneous B-cell lymphoma: a report of 7 cases.Fierro, MT., Savoia, P., Quaglino, P., et al.[2019]

References

Targeted therapies for non-Hodgkin lymphoma: rationally designed combinations. [2019]
Rituximab therapy of B-cell neoplasms. [2022]
Rituximab and its role as maintenance therapy in non-Hodgkin lymphoma. [2015]
Systemic therapy with cyclophosphamide and anti-CD20 antibody (rituximab) in relapsed primary cutaneous B-cell lymphoma: a report of 7 cases. [2019]
Improving therapeutic activity of anti-CD20 antibody therapy through immunomodulation in lymphoid malignancies. [2019]
Polatuzumab vedotin, an anti-CD79b antibody-drug conjugate for the treatment of relapsed/refractory diffuse large B-cell lymphoma. [2021]
Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell-Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial. [2023]
Salvage Using Polatuzumab Vedotin Based Therapy in Relapsed Refractory Large B-Cell Lymphomas: Early Experience from a Real-World Middle-Income Setting Using Named-Patient Compassionate Access Program. [2023]
A multicenter retrospective study of polatuzumab vedotin in patients with large B-cell lymphoma after CAR T-cell therapy. [2023]
Integrated summary of immunogenicity of polatuzumab vedotin in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Durable complete responses from therapy with combined epratuzumab and rituximab: final results from an international multicenter, phase 2 study in recurrent, indolent, non-Hodgkin lymphoma. [2017]
12.United Statespubmed.ncbi.nlm.nih.gov
Beyond rituximab: The future of monoclonal antibodies in B-cell non-Hodgkin lymphoma. [2021]
Glofitamab: First Approval. [2023]
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