ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma

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

Trial Details

NCT ID

NCT07021989

Phase

PHASE2

Sponsor

Michael Spinner, MD

Status

RECRUITING

Cancer Type

Non-Hodgkin Lymphoma Lymphoma

Interventions

Pembrolizumab
Non-investigational, involved site radiotherapy (ISRT)
Gemcitabine
Vinorelbine
Liposomal Doxorubicin
Foresight CLARITY™ LDT

Locations (sample)

Davis, California, United States|38.54491,-121.74052
Fresno, California, United States|36.74773,-119.77237
Irvine, California, United States|33.66946,-117.82311
La Jolla, California, United States|32.84727,-117.2742
Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

Age ≥ 18 years.
Histologically confirmed classic Hodgkin lymphoma (including nodular sclerosis, lymphocyte-rich, mixed cellularity, and lymphocyte-depleted Hodgkin…
Participants must have relapsed or refractory disease after no more than one line of systemic therapy. First line therapy must have included doxoru…
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.

For full eligibility, visit ClinicalTrials.gov.

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