A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma

ConditionLymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To assess the efficacy and safety of mosunetuzumab combined with zanubrutinib in patients with relapsed or refractory MZL.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically diagnosed marginal zone lymphoma (any subtypes)

Have received at least 1 prior treatment including CD20 monoclonal antibody

Patients have relapsed or refractory disease to their most recent regimen

Stage II, III or IV disease

Disqualifiers

Known active central nervous system lymphoma or leptomeningeal disease.

Treatment with any chemotherapeutic agent, or treatment with any other anti-lymphoma agent (investigational or otherwise) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to first investigational agent administration.

Adequately treated localized skin cancer without evidence of disease.

Adequately treated or monitored low risk localized prostate cancer.

Trial design

Design model

Single group

Treatments tested in this trial

  • Mosunetuzumab

    Drug

    Given by IV

  • Zanubrutinib

    Drug

    Given by IV

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Treatment w/Mosunetuzumab + ZanubrutinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety and Adverse Events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

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