Elranatamab consolidation for newly diagnosed plasmablastic lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1, single-arm, open-label feasibility trial evaluating Elranatamab as consolidation therapy for adults who achieved complete or partial response after frontline treatment for plasmablastic lymphoma. Patients receive a step-up subcutaneous dosing schedule followed by maintenance dosing for up to six cycles, with interim PET/CT assessments to monitor response. Disease status is then followed by PET/CT every 6 months for up to 2 years, plus routine clinical follow-up. The study aims to determine feasibility and tolerability of this consolidation approach in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Illinois at Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Paul Rubinstein, MD — university of Illinois Chicago Campus
• Study coordinator: Paul Rubinstein, MD
• Email: paulgr@uic.edu
• Phone: 312 413 1300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.