This is a single-arm feasibility trial in which patients with histologically confirmed plasmablastic lymphoma (PBL) with or without HIV, who have achieved a Complete Response or Partial Response after definitive frontline chemotherapy, will receive Elranatamab (Elra) consolidation.
Age ≥ 18 years at time of consent
ECOG PS 0 or 1
Histologically and immunophenotypically confirmed PBL
Ann Arbor stage at initial diagnosis: stage I with LDH > ULN and/or bulky disease >7.5 cm or stage II-IV
Prior BCMA bispecific therapy
Stable or progressive disease following front-line therapy as determined by the investigator
Receiving any other investigational agents
Expected survival < 2 months
Single group
Elranatamab (Elra)
DrugElra will be administered subcutaneously on day 1, day 4, then weekly on day 8, 15 and day 22 completing 1 cycle. Up to 6 cycles may be given.
Feasibility of giving Elra in consolidation after therapy of PBL
Evaluation of feasibility of (Elra) consolidation following definitive therapy in patients with PBL, defined as the proportion of patients completing at least 3 cycles (12 weeks) of consolidation therapy.
Estimate the complete response in HIV+/ HIV- patients
Estimate the complete response (CR) rate (per 2014 Lugano criteria)(1) for patients after 6 cycles of consolidation, stratified by HIV status.
Evaluate the safety and tolerability of Elra consolidation
To evaluate the safety and tolerability of Elra consolidation, including the incidence, severity, and management of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), assessed by ASTCT consensus criteria.
Assess event-free survival, progression-free and overall survival of Elra
Assess event-free survival (EFS), progression-free survival (PFS), and overall survival (OS) at 1- and 2-year post-completion of Elra consolidation
Estimate the conversion rate of PR to CR after consolidation
Estimate the conversion rate from pre-consolidation partial response (PR) to CR at the end of Cycle 3 and Cycle 6.
Evaluate quality of life (QoL) outcomes as measured by changes from baseline
Evaluate quality of life (QoL) outcomes as measured by changes from baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - High-Grade Non-Hodgkin Lymphoma 29 items (EORTC QLQ-NHL-HG29) scores.
Assess the effects of Elra on CD4 T-cell counts and HIV-1 viral load
Assess the effects of Elra on CD4 T-cell counts and HIV-1 viral load in people with HIV (PWH).
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University of Illinois at Chicago
Lead sponsor
Pfizer
Collaborator
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