HEME-25: Open-Label Feasibility Study of Elranatamab Utilized in Newly Diagnosed Plasmablastic Ly… (NCT07647432) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
HEME-25: Open-Label Feasibility Study of Elranatamab Utilized in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV
17 participantsStarted 2026-12-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Received definitive front-line therapy for PBL with end-of-treatment PR or CR
* Adequate bone marrow function with recovery from prior therapy, defined as:
* ANC ≥ 500 cells/mcL
* Platelet count ≥ 50,000 cells/mcL
* 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 Institutional Review Board (IRB) informed consent form and HIPAA authorization. If a subject is unable to consent, a 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:
Key inclusion criteria:
* Age ≥ 1…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of Elra consolidation therapy
Timeframe: 12 weeks ( 3 cycles)
2
Estimate the complete response in HIV+/ HIV- patients
Timeframe: 6 months
3
Evaluate the safety and tolerability of Elra consolidation