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 performance status (PS) 0 or 1
Histologically and immunophenotypically confirmed PBL
Ann Arbor stage at initial diagnosis: stage I with lactate dehydrogenase (LDH) > upper limit of normal (ULN) and/or bulky disease >7.5 cm or stage II-IV
Age ≥ 18 years at time of consent
ECOG performance status (PS) 0 or 1
Histologically and immunophenotypically confirmed PBL
Ann Arbor stage at initial diagnosis: stage I with lactate dehydrogenase (LDH) > upper limit of normal (ULN) and/or bulky disease >7.5 cm or stage II-IV
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.
Evaluation of Elra consolidation therapy
Evaluation of completion of (Elra) consolidation following definitive therapy in patients with PBL, defined as the proportion of patients completing at least 3 cycles
Estimate the complete response in HIV+/ HIV- patients
Estimate the complete response (CR) rate (per 2014 LUGANO criteria)Ref . in HIV-positive and HIV-negative patients after 6 months of consolidation.
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
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
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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