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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
Summary
This trial tests a combination of three treatments for patients with a type of cancer called Richter's transformation. The treatments include a personalized cell therapy, an immune-boosting drug, and a drug that stops cancer cells from growing. The goal is to see if this combination can better fight the cancer. Richter transformation is a condition where chronic lymphocytic leukemia (CLL) transforms into a more aggressive form of lymphoma.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete Response (CR)
Unacceptable Toxicity (UT)
Secondary study objectives
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
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Computed Tomography
2017
Completed Phase 2
~2740
Cyclophosphamide
2010
Completed Phase 4
~2320
Fludarabine
2012
Completed Phase 4
~1860
Ibrutinib
2014
Completed Phase 4
~2020
Nivolumab
2014
Completed Phase 3
~5220
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020
Pheresis
2017
Completed Phase 2
~10
Positron Emission Tomography
2011
Completed Phase 2
~2200
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Richter Syndrome, a transformation of chronic lymphocytic leukemia into a more aggressive form of lymphoma, is treated with various advanced therapies. Lisocabtagene Maraleucel (Liso-cel) is an autologous cellular immunotherapy that uses the patient's own modified T-cells to target and kill cancer cells, enhancing the body's immune response against the malignancy.
Nivolumab, a monoclonal antibody, works by inhibiting the PD-1 pathway, thereby boosting the immune system's ability to attack cancer cells. Ibrutinib, a kinase inhibitor, blocks the activity of Bruton's tyrosine kinase (BTK), which is essential for the growth and survival of cancer cells.
These treatments are crucial for Richter Syndrome patients as they offer targeted and effective options that can potentially lead to better outcomes by directly attacking the cancer cells and supporting the immune system's role in combating the disease.
Successful low-dose chemotherapy for refractory Epstein-Barr virus-related post-transplant lymphoproliferative disorder following hematopoietic stem cell transplantation in a child with Wiskott-Aldrich syndrome.Serendipity in splendid isolation: rapamycin.Rituximab for the treatment of post-bone marrow transplantation refractory hemolytic anemia in a child with Omenn's syndrome.
Successful low-dose chemotherapy for refractory Epstein-Barr virus-related post-transplant lymphoproliferative disorder following hematopoietic stem cell transplantation in a child with Wiskott-Aldrich syndrome.Serendipity in splendid isolation: rapamycin.Rituximab for the treatment of post-bone marrow transplantation refractory hemolytic anemia in a child with Omenn's syndrome.
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,517 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,980 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.
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