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Recruiting NCT07647432

HEME-25 Open-Label Feasibility Study of Elranatamab Utilized as Consolidation in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV

Conditions: Plasmablastic Lymphoma, HIV, Consolidation

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 17
Sponsor: University of Illinois at Chicago

Location: University of Illinois at Chicago Chicago Illinois

Summary

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.

Eligibility Criteria

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 * Hemoglobin ≥8 g/dL * Adequate renal function defined by an estimated creatinine clearance ≥30 mL/min (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or according to local institutional standard method). * Adequate hepatic function characterized by the following: * Total bilirubin ≤2 x ULN (≤3 x ULN if documented Gilbert's syndrome) * AST ≤2.5 x ULN * ALT ≤2.5 x ULN * Availability of archival tumor tissue (block or unstained slides) for mandatory central pathology review and correlative BCMA testing. Central pathology review and BCMA testing may be completed after enrollment. * Able to provide written informed consent and HIPAA authorization for release of personal health information via an approved UIC IRB ICF and HIPAA authorization. If a subject is unable to consent, an LAR may provide consent on their behalf. * As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study * If capable of becoming pregnant: Negative serum or urine pregnancy test * If HIV-positive: * Receiving effective combined antiretroviral therapy * CD4+ T-cell count ≥ 50 cells/mcL within 4 weeks before enrollment Exclusion criteria: * 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 * Known or suspected PBL involvement of the parenchymal brain or spinal cord at diagnosis. Asymptomatic leptomeningeal disease only will be allowed. * Uncontrolled intercurrent illness, including but not limited to uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Concurrent malignancy requiring active therapy within the last 3 years, except for the following: * Basal cell carcinoma limited to the skin * Squamous cell carcinoma limited to the skin * Carcinoma in situ of the cervix or breast * Adequately treated lentigo malignant melanoma * Localized prostate cancer * Active therapy consists of adjuvant or maintenance therapy to reduce the risk of recurrence of a malignancy that was previously treated with curative intent and with no evidence of active disease within 2 years prior to screening * Pregnant or nursing * PWH with a history of AIDS-defining opportunistic infection within the past year * Receipt of a live vaccine within 28 days prior to the first dose of study treatment

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07647432). StuddyBuddy aggregates publicly available trial information.