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Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma

ConditionsAnn Arbor Stage II Follicular LymphomaAnn Arbor Stage II Marginal Zone LymphomaAnn Arbor Stage III Follicular LymphomaAnn Arbor Stage III Marginal Zone LymphomaAnn Arbor Stage IV Follicular LymphomaAnn Arbor Stage IV Marginal Zone LymphomaGrade 1 Follicular LymphomaGrade 2 Follicular LymphomaGrade 3a Follicular Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

This phase II trial tests the safety, side effects and effectiveness of mosunetuzumab in treating patients with slow growing (indolent) B-cell lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older at time of signing informed consent

Capable of understanding and providing written informed consent

Follicular lymphoma (grade 1-2 or 3A)

Marginal zone lymphoma

Disqualifiers

History of severe allergic reaction to monoclonal antibody therapy

History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. Malignancies treated curatively or at low-risk of progressing at the judgment of the principal investigator (PI) may be included

Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection at study enrollment

Infection with human immunodeficiency virus (unless viral load is undetectable and CD4 count ≥ 200)

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood, oral, and/or rectal sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo PET/CT or CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Mosunetuzumab

    Biological/Vaccine

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Treatment (mosunetuzumab)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Overall response (OR)

OR will be defined as complete response and partial response at the end of therapy based on the latest version of Lugano criteria. Response rates will be calculated using simple binomial proportions and the corresponding 95% confidence interval will be derived.

Time frame
Up to week 13

Secondary outcomes

1

Incidence of adverse events (AE's)

All AEs will be graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be summarized by type, severity, duration, and attribution.

Time frame
Up to 30 days after last dose of study treatment
2

Incidence of grade 3 or greater cytokine release syndrome (CRS)

CRS will be graded by the American Society for Transplantation and Cellular Therapy Consensus Grading system.

Time frame
Up to 30 days after last dose of study treatment
3

Incidence of Immune Effector Cell Associated Neurotoxicity syndrome

Time frame
Up to 30 days after last dose of study treatment
4

Progression free survival (PFS)

Kaplan-Meier methodology will be used to estimate PFS.

Time frame
At initiation of study treatment to disease progression, up to 5 years

Other outcomes

Sponsors and contacts

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

University of Washington

Lead sponsor

Source ClinicalTrials.gov
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