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Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma

ConditionsAggressive Non-Hodgkin LymphomaALK-Positive Large B-Cell LymphomaDiffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedEBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedHigh Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 RearrangementsHigh Grade B-Cell Lymphoma, Not Otherwise SpecifiedPrimary Mediastinal Large B-Cell LymphomaT-Cell/Histiocyte-Rich Large B-Cell LymphomaGray-Zone Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

This phase I trial studies the side effects of polatuzumab vedotin when given with combination chemotherapy with or without glofitamab for the treatment of patients with untreated large B-cell lymphoma that grows and spreads quickly and has severe symptoms (aggressive). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Glofitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Drugs used in combination chemotherapy such as etoposide, cyclophosphamide, and doxorubicin work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving polatuzumab vedotin in combination chemotherapy with or without glofitamab may help treat patients with aggressive large B-cell lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocations

High grade B-cell lymphoma, not otherwise specified (NOS)

Diffuse large B-cell lymphoma (DLBCL) NOS

Primary mediastinal B-cell lymphoma

Disqualifiers

Contraindication to any of the individual components of glofitamab, tocilizumab or EPCH-R, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products

Prior systemic treatment for lymphoma with the exception of corticosteroids. Prior radiotherapy is allowed provided that this site is not used as a measurable site to assess response.

Richter's transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma is not allowed. Transformation from follicular or other indolent lymphomas is allowed provided that the subject has not received prior systemic therapy for their lymphoma and the aggressive component meets one of the criteria listed in inclusion criterion 1

Diagnosis of Burkitt lymphoma

Trial design

Design model

Parallel

Treatments tested in this trial

  • Polatuzumab Vedotin

    Drug

    Given IV

  • Rituximab

    Biological/Vaccine

    Given IV

  • Prednisone

    Drug

    Given PO

  • Etoposide

    Drug

    Given IV

  • Doxorubicin

    Drug

    Given IV

  • Cyclophosphamide

    Drug

    Given IV

  • Glofitamab

    Biological/Vaccine

    Given IV

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA scan

  • Echocardiography Test

    Procedure/Surgery

    Undergo echocardiography

  • FDG-Positron Emission Tomography

    Procedure/Surgery

    Undergo FDG-PET scan

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Arm A (polatuzumab vedotin, chemotherapy) [CLOSED TO ACCRUAL 05/23/2024]Experimental treatment 13 interventions
Group B: Arm B (polatuzumab vedotin, glofitamab, chemotherapy)Experimental treatment 14 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events

Will estimate the safety and tolerability of polatuzumab vedotin when added to dose-adjusted-etoposide, prednisone, vincristine (Oncovin), cyclophosphamide, doxorubicin-rituximab (DA-EPCH-R) with or without glofitamab, chemoimmunotherapy.

Time frame
Up to 30 days after last dose of polatuzumab or first administration of alternate therapy

Secondary outcomes

1

The proportion of patients who are unable to complete 6 cycles of therapy for reasons other than disease progression

Time frame
Up to 18 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

Genentech, Inc.

Collaborator

Source ClinicalTrials.gov
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