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Kinase Inhibitor
Liso-cel + Nivolumab + Ibrutinib for Richter Syndrome
Phase 2
Recruiting
Led By Tanya Siddiqi
Research Sponsored by City of Hope Medical Center
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 adds liso-cel to nivolumab & ibrutinib to fight Richter's transformation, using cells from patient's own blood to help the body's immune system fight cancer cells.
Who is the study for?
Adults (18+) with Richter's Transformation who've had at least two prior systemic therapies or relapsed within a year of first-line chemoimmunotherapy. They must have adequate organ function, not require oxygen supplementation, and agree to use effective birth control. Excluded are those with HIV, active hepatitis B/C, recent heart issues, autoimmune diseases (except mild conditions like controlled asthma), recent stem cell transplants, or on certain medications.Check my eligibility
What is being tested?
The trial is testing the combination of lisocabtagene maraleucel (liso-cel), nivolumab, and ibrutinib for treating Richter's transformation. Liso-cel uses the patient's own immune cells to fight cancer; nivolumab helps slow cancer growth by aiding the immune system; and ibrutinib blocks proteins that tell cancer cells to multiply.See study design
What are the potential side effects?
Potential side effects include immune system reactions causing inflammation in various organs, infusion-related reactions from liso-cel or nivolumab administration, fatigue from all three drugs being tested as well as possible liver enzyme changes due to ibrutinib.
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
Complete Response (CR)
Unacceptable Toxicity (UT)
Secondary outcome measures
Best Complete Response (CR)
Duration of Response (DOR)
Minimal Residual Disease (MRD)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, ibrutinib, chemotherapy, liso-cel)Experimental Treatment11 Interventions
Patients receive ibrutinib PO, nivolumab IV, fludarabine IV, cyclophosphamide IV, and liso-cel IV on study. Patients also undergo apheresis, PET/CT, biospecimen collection, and bone marrow biopsy on study. Patients may receive low-moderate intensity chemotherapy in combination with the study induction therapy per treating physician discretion with approval of study principal investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Positron Emission Tomography
2008
Completed Phase 2
~2240
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1730
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Computed Tomography
2017
Completed Phase 2
~2720
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100
Ibrutinib
2014
Completed Phase 3
~1880
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,440 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,270 Total Patients Enrolled
Tanya SiddiqiPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
91 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I had a stem cell transplant 3 months ago and don't have GVHD or need for immunosuppressants.I have not taken Warfarin in the 5 days before starting the treatment.I am a woman who can have children and my pregnancy test is negative.I haven't had chemotherapy, radiation, or immunotherapy in the last 14 days.I am able to get out of my bed or chair and move around.I have not had a stroke or brain bleed in the last 6 months.I had cancer before, but it was either removed surgically, treated on the skin, or has been inactive for 3+ years.I haven't taken strong CYP3A inducers in the last 14 days.I have a known history of HIV.I have a history of optic neuritis or other immune-related brain diseases.My heart condition severely limits my daily activities.I am not pregnant or breastfeeding.I need extra oxygen.I am capable of having children and have not been surgically sterilized.I have previously received PD1 or PD-L1 inhibitor therapy.I am currently taking antibiotics for an infection.I have an autoimmune disease but it's mild or well-controlled, like type I diabetes, hypothyroidism, certain skin conditions, or mild asthma.My hepatitis C or B viral load is undetectable.I have a bleeding disorder like von Willebrand's disease or hemophilia.My condition has been confirmed as Richter's Transformation.I am currently using steroids or immunosuppressants, but not inhaled steroids.I have recovered from side effects of cancer treatment, except for hair loss.I do not have any uncontrolled serious illnesses.My white blood cell count is healthy, unless my bone marrow is affected.I am approved to take liso-cel and ibrutinib as per their usage guidelines.I had a stem cell transplant using my own cells within the last 3 months.My cancer returned or didn't respond after 2 treatments, or within a year of chemoimmunotherapy.My heart rhythm problem is not controlled by medication.My lymphoma is only in the central nervous system.My kidneys are working well enough, as shown by a test.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab, ibrutinib, chemotherapy, 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.
Have the FDA granted approval to any of these interventions (nivolumab, ibrutinib, chemotherapy, liso-cel)?
"Our team's evaluation of the safety associated with Nivolumab, Ibrutinib, Chemotherapy and Liso-Cel scored a 2. This is because Phase 2 trials have some confirmation that it has no serious side effects but lack clinical evidence regarding its efficacy."
Answered by AI
Does this research endeavor currently offer participation to individuals?
"This particular medical trial is not currently recruiting, as stated on clinicaltrials.gov; the initial posting was May 5th 2023 and last update took place January 3rd 2023. However, 1487 other trials are open to enrollment at present."
Answered by AI
What is the primary aim of this medical experiment?
"The primary focus of this clinical trial, which will span up to 2 years in duration, is the assessment of Unacceptable Toxicity (UT). Secondary objectives include Best Complete Response (CR), Overall Response Rate (ORR), and Duration of Response (DOR) measurements. These metrics are obtained from starters who achieve CR or partial response before any disease progression or start of new anticancer treatment; patients not achieving a complete/partial response will be omitted from analysis. Kaplan-Meier product limit with log-log transformation for confidence interval estimation shall be used to measure DOR statistics."
Answered by AI
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