Protocol: SWOG – S2207
Please Note: Below is a partial list of eligibility, please contact the Genesys Hurley Cancer Institute, Research Department at (810)762-8181, (810)762-8079 or (810)762-8038 to discuss complete eligibility requirements. Thank you!
Eligibility:
- Histologically confirmed relapsed/refractory LBCL as outlined by the World Health Organization (WHO) guidelines, classified as one of the following: Large B-cell lymphoma, GBC and non-GCB types, Follicular lymphoma, grade 3B, Transformed lymphoma, High grade B-cell lymphoma with or without MYC, BCL2 and/or BCL6 rearrangements.
- Participants must have staging imaging performed within 28 days prior to registration, as follows. Positron emission tomography (PET)-computed tomography (CT) baseline scans are strongly preferred; diagnostic quality magnetic resonance imaging (MRI), contrast-enhanced CT, or contrast-enhanced MRI scans are also acceptable if PET-CT is not feasible at baseline.
- Participants must not have active lymphomatous involvement of the CNS because the treatments used in this study are not effective to sufficiently penetrate the blood
brain barrier. - Participants must not have known abnormalities associated with MDS (e.g., del 5q, chr 7 abn) and myeloproliferative neoplasms (MPN) (e.g., JAK2 V617F) observed in cytogenetic testing and DNA sequencing. Testing is not required for eligibility determination.
- Participants must not have a known prior history of T-LBL/T-ALL. Testing is not required for eligibility determination.
- Participants must have cell of origin (COO) determination of germinal center (GC)(GCB or non-GC GCB) of LBCL based on Hans immunohistochemistry algorithm (CD10, BCL6, MUM1) as noted on pathology report).
- Participants must not be a candidate based on investigator assessment to receive autologous stem cell transplant (ASCT) or must have declined ASCT. Participants who had disease progression after stem cell transplant or cellular therapy (such as chimeric antigen receptor (CAR) T-cell) are eligible.
- Participants must not have received prior treatment with tafasitamab and/or lenalidomide.
- Participants must not have had prior BTK inhibitor or tazemetostat.
- Participants must have had 1-5 prior systemic treatment regimens including one systemic multiagent regimen for aggressive lymphoma.
- Participants who have received prior systemic therapy must have completed their last treatment prior to registration. Participants must have recovered from previous therapy.
- Participants must not have any known allergy or reaction to any component of tafasitamab, lenalidomide, tazemetostat or zanubrutinib.
- Participants must not be receiving direct vitamin K inhibitors or strong or moderate CYP3A inhibitors or inducers at the date of registration.
- Participant must be ≥ 18 years old.
- Participant must have Zubrod Performance Status of 0-3.
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of
cardiac function using the New York Heart Association Functional Classification. - Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load
test on the most recent test results obtained within 6 months prior to registration. - Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere
with the safety or efficacy assessment of the investigational regimen. - Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on the most recent test results obtained within the last year and received suppressive therapy.
- Participants with a history of hepatitis C virus (HCV) infection must have an undetectable viral load. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 28 days prior to registration.