Study on Tafasitamab and Lenalidomide as First Treatment for Residual Large B Cell Lymphoma
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials ID:NCT06760156
This clinical trial is testing the safety and effectiveness of two drugs, tafasitamab and lenalidomide, in patients with Large B Cell Lymphoma who have previously been treated with axicabtagene ciloleucel (axi-cel). The study will last about 12 months.
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Program Overview
The aim of this study is to see if the combination of tafasitamab and lenalidomide is safe and works well in treating patients with Large B Cell Lymphoma (LBCL) who have already received a treatment called axicabtagene ciloleucel (axi-cel). Participants will be involved in the study for approximately one year.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of large B-cell lymphoma, including types like diffuse large B-cell lymphoma and others.
- Be 18 years or older.
- Be able to understand the study details and agree to follow all procedures and visits.
- Be willing to sign a consent form to participate.
- Have measurable disease on a PET/CT scan taken between 21 and 60 days after receiving CAR-T therapy with axicabtagene-ciloleucel.
- Have a performance status score of 0 to 2, indicating good overall health.
- Have adequate organ and bone marrow function.
- Have good liver and kidney function.
- Have an oxygen saturation level above 92% on room air.
- Women who can become pregnant must avoid pregnancy starting 4 weeks before and continuing through the study and for 4 weeks after, using two reliable birth control methods or abstaining from sex.
Exclusion Criteria
- Have received any experimental treatment within 4 weeks before the screening visit.
- Have cancer cells in the cerebrospinal fluid, brain metastases, or active central nervous system lymphoma after CAR T cell therapy.
- Have a history of central nervous system disorders like seizures or strokes.
- Have an uncontrolled infection requiring IV treatment.
- Have heart involvement with lymphoma.
- Have had a symptomatic blood clot in the lungs within 6 months before joining the study.
- Have a known primary immune deficiency.
- Have a history of autoimmune diseases requiring treatment in the last 2 years.
- Have had severe allergic reactions to lenalidomide or tafasitamab.
- Have any medical condition that might interfere with the study as determined by the doctor.
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