ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMichael Spinner, MD
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
Histologically confirmed classic Hodgkin lymphoma (including nodular sclerosis, lymphocyte-rich, mixed cellularity, and lymphocyte-depleted Hodgkin lymphoma).
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.
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- Pembrolizumab
- Non-investigational, involved site radiotherapy (ISRT)
- Gemcitabine
- Vinorelbine
- Liposomal Doxorubicin
- Foresight CLARITY™ LDT
- Pegfilgrastim
- Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computerized tomography (CT)
Treatment groups
38 Participants
are divided into 1 treatment groupSponsors and collaborators
Michael Spinner, MD
Lead sponsor
University of California, San Francisco
Sponsor institution
UC Hematologic Malignancies Consortium (UCHMC)
Collaborator
Foresight Diagnostics, Inc.
Collaborator
Natera, Inc.
Collaborator
Gateway for Cancer Research
Collaborator
Source ClinicalTrials.gov