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Treatment (mosunetuzumab, polatuzumab vedotin, lenalidomide) for Diffuse Large B-Cell Lymphoma
Phase 1
Recruiting
Led By Joseph M Tuscano
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically confirmed DLBCL NOS, high-grade B-cell lymphoma, or transformed indolent lymphoma as per the World Health Organization 2022 criteria
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new treatment for a specific type of lymphoma that has come back or has not responded to previous treatment. The treatment involves using three different drugs that work together to stop the growth
Who is the study for?
This trial is for adults with Diffuse Large B-Cell Lymphoma that has returned or didn't respond to previous treatments. They should have a life expectancy of at least 12 weeks, measurable disease by scans, and an ECOG performance status of 2 or better. Patients who've had CAR T-cell therapy or relapsed after other therapies may join, except those under 18 years old.Check my eligibility
What is being tested?
The trial tests a combination of three drugs: Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide in patients with relapsed/refractory DLBCL. It aims to find the safest doses and observe how well these drugs work together against cancer cells.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system due to monoclonal antibodies (Mosunetuzumab and Polatuzumab Vedotin), as well as risks associated with Lenalidomide such as blood clots, fatigue, digestive issues, and skin rash.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis is DLBCL, high-grade B-cell lymphoma, or transformed indolent lymphoma.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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I have a tumor that is larger than 1.5 cm, confirmed by a scan.
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I am 18 years or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of monsunetuzumab+polatuzumab vedotin+lenalidomide for determination of recommended phase 2 dose
Secondary outcome measures
Complete response rate
Duration of response
Objective response rate
+1 moreOther outcome measures
CAR T-cell expansion and persistence
CAR T-cell immunophenotypes
CD79b expression levels
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (mosunetuzumab, polatuzumab vedotin, lenalidomide)Experimental Treatment6 Interventions
Patients receive mosunetuzumab IV over 2-4 hours on days 1, 8, and 15 of cycle 1 and then day 1 of each subsequent cycle. Treatment repeats every 28 days for 8 cycles in patients who achieve a CR or up to 17 cycles for patients with a PR or SD in the absence of disease progression or unacceptable toxicity. Patients also receive polatuzumab vedotin IV over 30-90 minutes on day 1 for 6 cycles and lenalidomide PO on days 1-21 for 8 cycles in patients who achieve CR or up to 17 cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mosunetuzumab
2019
Completed Phase 2
~140
Positron Emission Tomography
2008
Completed Phase 2
~2240
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,411 Total Patients Enrolled
Joseph M TuscanoPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO
6 Previous Clinical Trials
239 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any ongoing efforts to enlist additional participants for this medical study?
"According to the current information available on clinicaltrials.gov, this clinical trial is actively enrolling participants. The initial posting of the trial occurred on September 3rd, 2024, and it was last updated on December 22nd, 2023."
Answered by AI
What is the upper limit on the number of individuals involved in this research endeavor?
"Indeed, the information available on clinicaltrials.gov indicates that this trial is currently in the process of recruiting eligible individuals. The trial was initially posted on September 3rd, 2024 and underwent its latest update on December 22nd, 2023. For this study, a total of 30 participants are being sought at a single location."
Answered by AI
To what extent do patients face potential risks associated with the administration of mosunetuzumab, polatuzumab vedotin, and lenalidomide as treatment options?
"Due to the limited data supporting safety and efficacy of the treatment (mosunetuzumab, polatuzumab vedotin, lenalidomide), our team at Power rates its safety as 1 on a scale from 1 to 3. This is in line with it being a Phase 1 trial."
Answered by AI
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