Phase 2 Study of Pembrolizumab and BEAM Therapy with Stem Cell Transplant for Relapsed Hodgkin Lymphoma
Sponsor: Masonic Cancer Center, University of Minnesota
ClinicalTrials ID:NCT06377540
This clinical trial is testing the effectiveness and safety of using Pembrolizumab with BEAM therapy before and after a stem cell transplant in patients with relapsed Hodgkin Lymphoma. The treatment involves receiving Pembrolizumab before the transplant and continuing it for a year after the transplant.
Patient Parameters
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Program Overview
The study aims to evaluate how well Pembrolizumab works when given with BEAM therapy before a stem cell transplant and continued as maintenance therapy for one year in patients with relapsed Hodgkin Lymphoma. Participants will receive Pembrolizumab every three weeks starting 28 days before the transplant and continue for a year after the transplant.
Eligibility Criteria
Inclusion Criteria
- Eligible for a stem cell transplant using the BEAM therapy regimen.
- Have a performance status score indicating good health (KPS greater than 70 or ECOG 0 or 1).
- Have adequate organ function and blood counts within 14 days before joining the study.
- If positive for hepatitis B, must have been on antiviral therapy for at least 4 weeks and have no detectable virus before starting the study.
- If previously infected with hepatitis C, must have no detectable virus at screening.
- If HIV-positive, must have well-controlled HIV on antiretroviral therapy.
Exclusion Criteria
- History of severe autoimmune reaction to PD-1 inhibitors.
- Received radiation therapy within 2 weeks before starting the study or have radiation-related side effects needing steroids.
- Received a live vaccine within 30 days before starting the study (killed vaccines are allowed).
- Received chemotherapy within 3 weeks before starting the study.
- Have active disease in the central nervous system.
- Have a history of or active autoimmune disease needing systemic steroids or autoimmune drugs, except for certain conditions like vitiligo or controlled hypothyroidism.
- Have had a tissue or organ transplant from another person.
- Pregnant or breastfeeding women cannot participate due to potential risks. Women of childbearing potential must have a negative pregnancy test within 14 days before joining the study.
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