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CAR T-cell Therapy
Zanubrutinib + CAR T-Cell Therapy for Richter's Syndrome
Phase 2
Recruiting
Led By Adam S Kittai, MD
Research Sponsored by Adam Kittai
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 up to 2 years
Awards & highlights
Study Summary
This trial tests a combination of drugs to treat Richter's syndrome, a type of cancer of the lymph nodes. The drugs stop abnormal proteins that tell cancer cells to multiply & also change immune cells to attack cancer.
Who is the study for?
Adults with Richter's syndrome, a condition where chronic lymphocytic leukemia transforms into aggressive lymphoma. Participants must have relapsed or refractory disease after at least one treatment cycle, adequate organ function, and meet criteria for CAR T-cell therapy. They should not be pregnant or breastfeeding and must agree to effective contraception.Check my eligibility
What is being tested?
The trial is testing the combination of zanubrutinib (a kinase inhibitor that stops cancer cells from multiplying) and lisocabtagene maraleucel (CAR T-cell therapy that modifies patient's immune cells to attack cancer). The goal is to see if this combo is more effective in treating Richter's syndrome.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion, changes in blood counts leading to increased infection risk, fatigue, issues with organs like the heart or liver due to inflammation caused by treatments, and possible complications from modifying the immune system.
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
Overall response rate
Secondary outcome measures
Duration of response
Incidence of adverse events
Overall survival
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (zanubrutinib, liso-cel)Experimental Treatment10 Interventions
Patients receive zanubrutinib PO, undergo leukaphereis, and receive fludarabine IV, cyclophosphamide IV, and liso-cel IV on study. Patients also undergo BM biopsy and lymph node biopsy at screening and follow up, and undergo collection of blood samples and CT, PET/CT, and/or MRI throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2240
Leukapheresis
2016
Completed Phase 2
~690
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100
Biospecimen Collection
2004
Completed Phase 2
~1700
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Computed Tomography
2017
Completed Phase 2
~2720
Lymph Node Biopsy
2014
Completed Phase 2
~50
Zanubrutinib
2017
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Adam KittaiLead Sponsor
Adam S Kittai, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
52 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another serious illness that may shorten my life to under 5 years.I have a heart condition.I have large B-cell lymphoma with a history of CLL.My condition has not improved or has worsened despite treatment.I have not had certain treatments recently.I still have side effects from my previous cancer treatment.I am taking specific medications as required.I am HIV positive.I meet the requirements for CAR T-cell therapy at my treatment center.I am currently taking medication that affects enzyme activity.I have certain medical conditions or diseases.I have an autoimmune disease and need specific medication for it.I have not received any live vaccines in the last 28 days.I do not have any unmanaged ongoing illnesses.My blood tests show abnormal cell changes.I regularly use corticosteroids.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (zanubrutinib, liso-cel)
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.
Has the FDA validated these therapies (zanubrutinib, liso-cel) for use?
"Treatment (zanubrutinib, liso-cel) was ranked a score of 2 on our safety assessment scale due to the lack of clinical evidence regarding its efficacy. Nonetheless, there is some data confirming its security."
Answered by AI
Are there any vacancies available for individuals interested in participating in this medical experiment?
"As displayed on clinicaltrials.gov, this investigation is no longer enrolling patients; the trial was initially posted in June 1st 2023 and its last update happened May 15th of the same year. Nevertheless, there are currently 3808 other trials which need volunteers right now."
Answered by AI
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