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

A vizsgálat adatai

Ki végzi

University of Illinois Chicago

Azonosító

NCT07647432

A regiszteradat frissítve

2026. október 26.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

HEME-25 Open-Label Feasibility Study of Elranatamab Utilized in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV in Consolidation After Definitive Therapy (The EPIC Study)

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.

Bevonási feltételek: 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.

Kizáró feltételek: Prior BCMA bispecific therapy; Receiving any other investigational agents; 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; Receipt of a live vaccine within 28 days prior to the first dose of study treatment; Stable or progressive disease following front-line therapy as determined by the investigator; 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; PWH with a history of AIDS-defining opportunistic infection within the past year; Expected survival < 2 months; Pregnant or nursing.

ClinicalTrials.gov NCT07647432