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Immunomodulatory Agent
Combination Therapy for Non-Hodgkin's Lymphoma
Phase 2
Recruiting
Led By Jennifer E Amengual
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization to date of first observation of progressive disease according to the 2014 lugano classification, or death due to any cause, assessed up to 3 years
Awards & highlights
Study Summary
This trial tests a combination of 4 meds to treat large B-cell lymphoma. Its goal is to shrink the cancer & extend time without symptoms returning.
Who is the study for?
Adults with high-grade B-cell lymphoma that has returned or is resistant to treatment can join this trial. They must have had 1-5 prior treatments, be in relatively good health based on specific blood and liver function tests, and not be pregnant or breastfeeding. People with central nervous system involvement, allergies to the drugs used, certain other cancers, or those who are candidates for stem cell transplant are excluded.Check my eligibility
What is being tested?
The trial is testing a combination of tazemetostat (an EZH2 inhibitor), zanubrutinib (a kinase inhibitor), tafasitamab (a monoclonal antibody), and lenalidomide (an immunomodulatory agent) against large B-cell lymphoma. It aims to find the best dose and see how well these drugs work together after previous treatments failed.See study design
What are the potential side effects?
Potential side effects include reactions related to immune response such as inflammation in organs, infusion-related reactions like fever or chills, fatigue from treatment burden, digestive issues including nausea or diarrhea, blood disorders like anemia or clotting problems, increased risk of infections due to weakened immunity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization to date of first observation of progressive disease according to the 2014 lugano classification, or death due to any cause, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization to date of first observation of progressive disease according to the 2014 lugano classification, or death due to any cause, assessed up to 3 years
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)
Trial Outcome Index (TOI) score from the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) (Patient Reported Outcome [PRO] Study)
Secondary outcome measures
Complete response (CR) rate
Duration of response (DOR)
Event free survival (EFS)
+7 moreTrial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib)Experimental Treatment9 Interventions
Patients receive tafasitamab IV, lenalidomide PO, and zanubrutinib PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
Group II: Part II, Arm I (tafasitamab, lenalidomide, tazemetostat)Experimental Treatment9 Interventions
Patients receive tafasitamab IV, lenalidomide PO, and tazemetostat PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
Group III: Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib)Experimental Treatment9 Interventions
Patients receive tafasitamab IV, lenalidomide PO, and zanubrutinib PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
Group IV: Part I, Arm I (tafasitamab, lenalidomide, tazemetostat)Experimental Treatment8 Interventions
Patients receive tafasitamab IV, lenalidomide PO, and tazemetostat PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
Group V: Part II, Arm II (tafasitamab, lenalidomide)Active Control8 Interventions
Patients receive tafasitamab IV and lenalidomide PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
2017
Completed Phase 3
~1940
Tafasitamab
2016
Completed Phase 2
~180
Computed Tomography
2017
Completed Phase 2
~2720
Lenalidomide
2005
Completed Phase 3
~1480
Positron Emission Tomography
2008
Completed Phase 2
~2240
Tazemetostat
2016
Completed Phase 2
~780
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biospecimen Collection
2004
Completed Phase 2
~1700
Find a Location
Who is running the clinical trial?
IpsenIndustry Sponsor
346 Previous Clinical Trials
73,073 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
264,943 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,214 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself, but I might not be able to do heavy physical work.My cancer has not spread to my brain or spinal cord.I have grade 3B Follicular lymphoma.My large B-cell lymphoma has come back or didn't respond to treatment, as confirmed by tests.I am 18 years old or older.My lymphoma is high grade with possible genetic changes.I have never taken BTK inhibitors or tazemetostat.I have recovered from side effects of previous cancer treatments, except for hair loss.My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.I've had a full medical check-up in the last 28 days.I have never been treated with tafasitamab or lenalidomide.I have never been diagnosed with T-cell lymphoblastic lymphoma or T-cell acute leukemia.If I can't make decisions, my legal representative can consent for me.I am not eligible for or have declined a stem cell transplant. I may have had disease progression after a transplant.My large B-cell lymphoma has been classified as GC or non-GC based on specific protein markers.I've had 1-5 treatments for aggressive lymphoma, including a multi-drug regimen.I am not taking vitamin K inhibitors or certain strong medications.I can take pills and don't have major gut issues affecting medicine absorption.I can fill out health forms in English or Spanish and agree to participate in a study.My lymphoma has changed into a more aggressive form.My heart is healthy enough for the trial, meeting the NYHA class 2B or better.I have chronic hepatitis B but my viral load is undetectable and I am on suppressive therapy.I don't have another cancer that could affect this treatment's safety or results.I am not allergic to tafasitamab, lenalidomide, tazemetostat, or zanubrutinib.I had hepatitis C but now have no detectable virus, or I am being treated and my latest test shows no virus.I have HIV, am on effective treatment, and my last test showed undetectable virus levels.I don't have genetic issues linked to specific blood disorders.I am not pregnant or nursing and will follow safe sex or contraceptive guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Part I, Arm I (tafasitamab, lenalidomide, tazemetostat)
- Group 2: Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib)
- Group 3: Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib)
- Group 4: Part II, Arm I (tafasitamab, lenalidomide, tazemetostat)
- Group 5: Part II, Arm II (tafasitamab, lenalidomide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment providing opportunities to enrol participants?
"According to clinicaltrials.gov, this investigation is currently seeking participants. Initially posted on September 1st 2023 and most recently modified on July 21st 2023, the trial's details remain current."
Answered by AI
How many participants are welcome to join this clinical trial?
"Affirmative, according to the information uploaded on clinicaltrials.gov this medical trial is still recruiting participants. The study was initially launched on September 1st 2023 and most recently modified on July 21st 2023; it requires 227 patients from one site for successful completion."
Answered by AI
Have the agencies given their authorization to utilize tafasitamab, lenalidomide, and zanubrutinib in Part II, Arm III?
"Considering the lack of evidence for efficacy and some data indicating safety, Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib) was given a score of 2."
Answered by AI
What is the ultimate objective of this experiment?
"The main purpose of this trial is to assess the Trial Outcome Index (TOI) score from the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym). Secondary goals include computing Hazard ratio for PFS in non-GCB subgroup, Partial response rate and Duration of response in both GCB and non-GCB LBCL groups. This data will be collected over a three year period starting at randomization until progressive disease or death due to any cause occurs."
Answered by AI
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