Testing Mosunetuzumab Alone, With Zanubrutinib, or With Polatuzumab Vedotin for Treating Marginal Zone Lymphoma That Came Back or Didn't Get Better With Treatment

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSWOG Cancer Research Network

About this trial

This phase II trial compares the effect of mosunetuzumab alone to mosunetuzumab with zanubrutinib or polatuzumab vedotin in patients with marginal zone lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Mosunetuzumab 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). Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as marginal zone lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug, called monomethyl auristatin E. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD79B receptors, and delivers monomethyl auristatin E to kill them. Giving mosunetuzumab alone or with zanubrutinib or polatuzumab vedotin may work well for treating relapsed or refractory marginal zone lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have histologically diagnosed CD20+ marginal zone lymphoma (MZL) as per World Health Organization (WHO) criteria including splenic, nodal, and extranodal subtypes, but excluding gastrointestinal-only marginal zone lymphoma (MZL) with disease assessments that can only be evaluated through endoscopic methods and cutaneous-only MZL.

The participant has received prior CD3/CD20 bispecific antibody, then a repeat biopsy to document continued CD20+ MZL disease is required after the completion of the prior CD3/CD20 bispecific antibody therapy and prior to study registration.

The participant has splenic MZL in which a bone marrow biopsy pre-registration is required within 42 days prior to registration

Participants must have measurable disease by PET-CT (preferred), or CT as defined by extranodal lesion ≥ 1cm or nodal lesion ≥ 1.5cm.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Mosunetuzumab

    Biological/Vaccine

    Given SC

  • Polatuzumab Vedotin

    Drug

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET scan

  • Survey Administration

    Other intervention

    Ancillary studies

  • Zanubrutinib

    Drug

    Given PO

Treatment groups

138 Participants
are divided into 3 treatment groups
Group A: Arm 1 (mosunetuzumab)Experimental treatment 6 interventions
Group B: Arm 2 (mosunetuzumab and zanubrutinib)Experimental treatment 7 interventions
Group C: Arm 3 (mosunetuzumab and polatuzumab vedotin)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Complete response rate (arm 1 versus arm 2)

Defined by the Lugano Classification.

Time frame
Up to 5 years
2

Complete response rate (arm 1 versus arm 3)

Defined by the Lugano Classification.

Time frame
Up to 5 years

Secondary outcomes

1

Progression free survival

Will be calculated using the method of Kaplan-Meier and compared using a log-rank test.

Time frame
From date of randomization to date of first observation of progressive disease, transformation to diffuse large B cell lymphoma, or death due to any cause, up to 5 years
2

Overall survival

Will be calculated using the method of Kaplan-Meier and compared using a log-rank test.

Time frame
From date of randomization to date of death due to any cause, up to 5 years
3

Overall response rate

Defined as complete responses and partial responses.

Time frame
Up to 5 years
4

Duration of response

Will be calculated using the method of Kaplan-Meier and compared using a log-rank test.

Time frame
From date of first documentation of response to treatment to date of first documentation of progression, transformation to diffuse large B cell lymphoma, or death due to any cause among participants who achieve a response, up to 5 years

Other outcomes

1

Incidence of symptomatic adverse events

Will be evaluated utilizing Patient Reported Outcomes-Common Terminology Criteria for Adverse Events.

Time frame
Up to 5 years

Locations

This trial has no locations.

Sponsors and contacts

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

SWOG Cancer Research Network

Lead sponsor

National Cancer Institute (NCI)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: