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Chemotherapy

Treatment (Mosunetuzumab and EPOCH) for Non-Hodgkin's Lymphoma

Phase 1 & 2

Waitlist Available

Led By Stephen E Spurgeon

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be 18-75 years of age

Participant must have Stage II or higher and International Prognostic Index (IPI) score of 2-5

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a combination of a monoclonal antibody called mosunetuzumab and chemotherapy for treating patients with certain types of lymphoma. The monoclonal

Who is the study for?

This trial is for patients with untreated high grade B cell lymphoma or diffuse large B cell lymphoma that tests positive for c-Myc rearrangement. Participants should not have had previous treatments and must be suitable for immunotherapy and chemotherapy.Check my eligibility

What is being tested?

The trial is testing mosunetuzumab, a monoclonal antibody, combined with chemotherapy drugs (etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone) to see if they're safe and effective against certain types of B cell lymphoma.See study design

What are the potential side effects?

Possible side effects include reactions to the infusion of mosunetuzumab such as fever or chills; low blood counts leading to increased infection risk; nausea; hair loss; nerve damage causing numbness or tingling; and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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My cancer is at least Stage II and has a moderate to high risk score.

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I have at least one measurable cancerous lesion.

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I can take care of myself and am up and about more than half of my waking hours.

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I have high-grade B cell lymphoma or DLBCL with a specific genetic change.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of dose limiting toxicities (DLTs) (phase Ib)

Proportion of patients with complete response by positron emission tomography-computed tomography (PET-CT) (phase II)

Secondary outcome measures

Duration of response (DOR)

Incidence of ≥ grade 3 toxicities possibly or definitely related to mosunetuzumab

Number of cycles completed and dose received of DA EPOCH

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Mosunetuzumab and EPOCH)Experimental Treatment14 Interventions

Patients receive mosunetuzumab IV, over 2-4 hours, on day 1, 8 and 15 of cycle 1 and day 1 of subsequent cycles. Patients receive etoposide IV, doxorubicin IV, and vincristine IV on days 1-4, cyclophosphamide IV, over 2 hours, on day 5 and prednisone PO BID on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity for up to 6 cycles. Patients undergo bone marrow aspiration and biopsy, tumor biopsy and may undergo echocardiography or MUGA at screening and PET scan, CT scan or MRI and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Biopsy

2014

Completed Phase 4

~1090

Etoposide

2010

Completed Phase 3

~2440

Computed Tomography

2017

Completed Phase 2

~2720

Cyclophosphamide

1995

Completed Phase 3

~3770

Echocardiography

2013

Completed Phase 4

~11670

Doxorubicin

2012

Completed Phase 3

~7940

Vincristine

2003

Completed Phase 4

~2910

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Mosunetuzumab

2019

Completed Phase 2

~140

Positron Emission Tomography

2008

Completed Phase 2

~2240

Prednisone

2014

Completed Phase 4

~2370

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

568,103 Total Patients Enrolled

OHSU Knight Cancer InstituteLead Sponsor

230 Previous Clinical Trials

2,090,686 Total Patients Enrolled

Oregon Health and Science UniversityOTHER

975 Previous Clinical Trials

7,386,172 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction for individuals participating in this medical study, specifically pertaining to those over the age of 25?

"The research team is seeking individuals older than 18 years but younger than 75 years to participate in the trial."

Answered by AI

Is the enrollment for this study currently open?

"As per the details on clinicaltrials.gov, it is evident that this specific trial is presently not seeking new participants. The trial was initially listed on March 1st, 2024, and had its latest update on January 31st, 2024. Despite this study being temporarily closed for enrollment, there are a substantial number of 1733 alternative trials actively recruiting eligible individuals at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mosunetuzumab With Chemotherapy for the Treatment of Patients With Untreated C-Myc Rearrangement Positive High Grade B Cell Lymphoma or Diffuse Large B Cell Lymphoma

Stephen Spurgeon 2024. "Mosunetuzumab With Chemotherapy for the Treatment of Patients With Untreated C-Myc Rearrangement Positive High Grade B Cell Lymphoma or Diffuse Large B Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06249191.

All > Diffuse Large B Cell Lymphoma