Study on Lisocabtagene Maraleucel, Nivolumab, and Ibrutinib for Treating Richter's Transformation
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT05672173
This clinical trial is exploring how well a combination of three treatments—lisocabtagene maraleucel, nivolumab, and ibrutinib—works for patients with Richter's transformation, a type of cancer. The study aims to see if these treatments can help the immune system fight cancer more effectively.
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Program Overview
This study is testing a new treatment approach for patients with Richter's transformation, a type of cancer that occurs when chronic lymphocytic leukemia (CLL) transforms into a more aggressive form. The trial combines three treatments: lisocabtagene maraleucel (a type of immunotherapy using the patient's own cells), nivolumab (an antibody that helps the immune system slow cancer growth), and ibrutinib (a drug that blocks signals that tell cancer cells to grow). Researchers want to find out if this combination can kill more cancer cells and improve patient outcomes.
Description
The main goals of this study are to see how well the combination of lisocabtagene maraleucel, nivolumab, and ibrutinib works in treating Richter's transformation and to check for any serious side effects. Researchers will look at how many patients have a complete response to the treatment after three cycles and monitor any unacceptable side effects in the first month.
Secondary goals include assessing the overall safety of the treatment, estimating the best response rates, and determining how long patients stay in remission. The study will also explore how the treatment affects cancer cells and the immune system.
Participants will receive the study drugs through oral and intravenous methods, along with other procedures like blood tests, scans, and biopsies. Some patients may also receive additional chemotherapy based on their doctor's recommendation.
Eligibility Criteria
Inclusion Criteria
- Must provide informed consent to participate.
- Agree to a tumor biopsy before starting treatment, unless it's too risky.
- Must be 18 years or older.
- Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have a confirmed diagnosis of Richter's Transformation.
- Have tried at least two previous treatments without success, or the cancer returned within a year after initial treatment.
- Eligible to receive lisocabtagene maraleucel and ibrutinib.
- Must have recovered from previous cancer treatments.
- Meet specific blood count and organ function requirements.
- Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for five months after the last treatment.
Exclusion Criteria
- Have previously received PD1 or PD-L1 inhibitor therapy.
- Have had a stem cell transplant within the last three months.
- Have received chemotherapy, radiation, or immunotherapy within the last 14 days.
- Are currently using strong CYP3A inducers or warfarin.
- Require oxygen supplementation.
- Are using systemic steroids or immunosuppressants, except for certain conditions.
- Have lymphoma only in the central nervous system.
- Have severe heart conditions or arrhythmias.
- Have a history of optic neuritis or other central nervous system diseases.
- Have known allergies to similar study drugs.
- Have bleeding disorders or recent history of stroke.
- Have other active cancers, except for certain types treated with curative intent.
- Have uncontrolled illnesses or active infections.
- Are pregnant or breastfeeding.
- Have an active autoimmune disease, except for certain controlled conditions.
- Have any condition that might make it unsafe to participate in the study.
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