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Post-CAR T-cell Therapy Drug Combo for Non-Hodgkin's Lymphoma

Phase 2
Recruiting
Led By Brian T Hess
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with transformed DLBCL must have transformed DLBCL from follicular or marginal zone lymphoma
Participant must have bi-dimensionally measurable systemic disease (at least one lesion with longest diameter > 1.5 cm)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial tests if a drug combo can help cancer patients after chemo & CAR T-cell therapy. The combo targets cancer cells to help shrink or control them.

Who is the study for?
This trial is for adults with certain types of lymphoma (like diffuse large B-cell or follicular grade IIIb) that's come back or isn't responding to treatment. They should be set for CAR T-cell therapy, have a decent performance score, and functioning major organs. People can't join if they've had recent heart issues, used specific drugs as 'bridging' therapy, or if their CAR T-cells aren't FDA-approved.Check my eligibility
What is being tested?
The study tests mosunetuzumab and polatuzumab vedotin in patients who've had chemotherapy followed by CAR T-cell therapy. It aims to see if these drugs help control the cancer better post-CAR T-cell treatment compared to not using them.See study design
What are the potential side effects?
Mosunetuzumab and polatuzumab vedotin might cause side effects like allergic reactions, liver problems from hepatitis B or C reactivation, nerve damage symptoms (peripheral neuropathy), low blood cell counts increasing infection risk, fatigue, and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My DLBCL cancer developed from follicular or marginal zone lymphoma.
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I have a tumor larger than 1.5 cm.
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I am eligible for a specific immune therapy according to FDA guidelines.
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I have CNS lymphoma but no symptoms from it.
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I am 18 years old or older.
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I have been diagnosed with a specific type of lymphoma.
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My nerve damage does not severely affect my daily activities.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I had hepatitis C but have completed treatment, have no liver damage from it, and my viral load is undetectable.
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I have hepatitis B with no liver damage and am on treatment that controls the virus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Progression free survival (PFS)
Secondary outcome measures
Association between total metabolic tumor volume (TMTV), standardized uptake value (SUV) max, and sum product (SPD) of diameters
Complete remission (CR) conversion rate
Conversion of CR
+2 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Step II Arm III (polatuzumab vedotin, mosunetuzumab)Experimental Treatment5 Interventions
Patients receive polatuzumab vedotin IV and mosunetuzumab IV on study. Patients also undergo PET-CT and/or CT and undergo collection of blood and tissue samples throughout the study.
Group II: Step II Arm II (polatuzumab vedotin)Experimental Treatment4 Interventions
Patients receive polatuzumab vedotin IV on study. Patients also undergo PET-CT and/or CT and undergo collection of blood and tissue samples throughout the study.
Group III: Step II Arm I (mosunetuzumab)Experimental Treatment4 Interventions
Patients receive mosunetuzumab IV on study. Patients also undergo PET-CT and/or CT and undergo collection of blood and tissue samples throughout the study.
Group IV: Step I (lymphodepleting chemotherapy)Experimental Treatment6 Interventions
Patients receive lymphodepleting chemotherapy consisting of fludarabine IV and cyclophosphamide IV on study. Patients then receive tisagenlecleucel IV, axicabtagene ciloleucel IV, or lisocabtagene maraleucel IV on study.
Group V: Step II Arm IV (observation)Active Control4 Interventions
Patients undergo observation on study. Patients also undergo PET-CT and/or CT and undergo collection of blood and tissue samples throughout the study. Patients with subsequent progression within 12 months of CAR T-cell therapy may crossover to Arm III.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axicabtagene Ciloleucel
2015
Completed Phase 2
~500
Biospecimen Collection
2004
Completed Phase 2
~1920
Positron Emission Tomography
2008
Completed Phase 2
~2260
Computed Tomography
2017
Completed Phase 2
~2790
Tisagenlecleucel
2019
Completed Phase 2
~360
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1100
Mosunetuzumab
2019
Completed Phase 2
~140
Polatuzumab Vedotin
2019
Completed Phase 2
~820

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,214 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,345 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,626 Previous Clinical Trials
40,927,239 Total Patients Enrolled

Media Library

Step I (lymphodepleting chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05633615 — Phase 2
Follicular Lymphoma Research Study Groups: Step I (lymphodepleting chemotherapy), Step II Arm III (polatuzumab vedotin, mosunetuzumab), Step II Arm IV (observation), Step II Arm I (mosunetuzumab), Step II Arm II (polatuzumab vedotin)
Follicular Lymphoma Clinical Trial 2023: Step I (lymphodepleting chemotherapy) Highlights & Side Effects. Trial Name: NCT05633615 — Phase 2
Step I (lymphodepleting chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05633615 — Phase 2

Frequently Asked Questions

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

Are there any current openings for individuals to participate in this clinical trial?

"Current data on clinicaltrials.gov implies that this research project is actively searching for participants. The trial was initially posted on the 23rd of February 2023 and last modified on 13th March 2021."

Answered by AI

What risks are associated with the use of Step II Arm II (polatuzumab vedotin) for patients?

"Taking into account its phase 2 status, Power has rated the safety of Step II Arm II (polatuzumab vedotin) as a 2. Though there is data demonstrating relative safety, no evidence exists to support efficacy."

Answered by AI

How many participants have been invited to join the research initiative?

"Affirmative. Clinicaltrials.gov displays that the trial, whose initial posting was on February 23rd 2023 is actively looking for participants. 396 individuals must be enrolled in total from a single location."

Answered by AI
~186 spots leftby Dec 2024