University of Illinois at Chicago
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.
Patients after definitive therapy will receive Elra subcutaneously for up to six 28-day cycles, beginning with a step-up dosing schedule (12 mg on day 1, 32 mg on day 4, followed by 76 mg weekly on days 8, 15, and 22 of Cycle 1). Patients will transition to 76 mg every 2 weeks (days 1 and 15) during Cycles 2 and 3, followed by an interim PET/CT assessment at the end of Cycle 3. During cycles 4 through 6, all patients will receive 76 mg every 4 weeks (on day 1 of each cycle). Participants will undergo disease assessment with PET/CT at the end of Cycle 3, post-end of treatment (EOT) visit, and…
Inclusion Criteria: * 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 * Received definitive front-line therapy for PBL with end-of-treatment PR or CR. Date of end-of-treatment response evaluation must be within 8 weeks prior to enrollment. * Adequate bone marrow function with recovery from prior therapy (without growth factor or transfusion support), defined as: * ANC ≥ 500 cells/mcL * Platelet count ≥ 50,000 cells/mcL *…
Elra 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.
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