ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma
United States38 participantsStarted 2026-05-01
Plain-language summary
This is a single arm, open-label, multicenter, phase II study of pembrolizumab (pembro), gemcitabine, vinorelbine, and liposomal doxorubicin (GVD) in patients with relapsed or refractory classic Hodgkin lymphoma (cHL) with response-adapted consolidation. This study will investigate using circulating tumor DNA (ctDNA) at pre-determined time points using Foresight CLARITY LDT, an ultra-sensitive liquid biopsy platform that detects Minimal residual disease (MRD) in patients with B-cell lymphomas using the phased variant enrichment and sequencing technology (PhasEDq) to determine response to study interventions.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Participants must have relapsed or refractory disease after no more than one line of systemic therapy. First line therapy must have included doxorubicin.
✓. At least one site of FDG-avid disease on PET/CT that is ≥ 1.5 cm in diameter for nodal disease or ≥ 1.0 cm in diameter if extranodal disease.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky ≥ 50%).
✓. Demonstrates adequate organ function as defined below:
✓. Absolute neutrophil count (ANC) ≥ 1.0 X 10\^9/ L (1000/microliter (mcL), growth factors permitted).
✓. Platelets ≥ 75 X 10\^9 / L (75,000/mcL, platelet transfusion independent).
Exclusion criteria
✕. Participants who previously received a programmed cell death protein 1 (PD-1) inhibitor-based regimen (e.g., nivolumab or pembrolizumab + AVD) and progressed within 6 months of last done of immune checkpoint inhibitor.
What they're measuring
1
Percentage of participants with a complete response
✕. Receipt of systemic anti-cancer therapies or radiation within 2 weeks prior to the start of trial therapy or receipt of antibody therapy within 4 weeks prior to the start of trial therapy.
✕. Has participated in a study of an investigational product and received study treatment or used an investigational device within four weeks of the first dose of treatment.
✕. Prior autologous or allogeneic hematopoietic stem cell transplant.
✕. Systemic autoimmune disease requiring continuous immunosuppressive treatment (≥prednisone 10 mg per day or equivalent), with the exception of autoimmune thyroid disease.
✕. Left ventricular ejection fraction (LVEF) \<50% as assessed by transthoracic echocardiogram or multigated acquisition (MUGA) scan.
✕. Participants whose lifetime cumulative dose of doxorubicin would exceed 450 mg/m\^2 after receiving 4 cycles of pembro + GVD are excluded (i.e., \>330 mg/m\^2 at trial entry).
✕. Has known hypersensitivity to pembrolizumab, gemcitabine, vinorelbine, and/or liposomal doxorubicin; or any of their excipients.