ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma

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.

Conditions

• Hodgkin Lymphoma, Adult
• Refractory Hodgkin Lymphoma
• Classic Hodgkin Lymphoma

Interventions

DRUG

Pembrolizumab

Given intravenously

RADIATION

Non-investigational, involved site radiotherapy (ISRT)

Undergo possible, standard of care, non-investigational radiation therapy

DRUG

Gemcitabine

Given IV

DRUG

Vinorelbine

Given IV

DRUG

Liposomal Doxorubicin

Given IV

DEVICE

Foresight CLARITY™ LDT

Foresight CLARITY LDT, a laboratory-developed test (LDT),by Foresight Diagnostics, is an ultra-sensitive liquid biopsy and tissue platform that detects MRD in patients with B-cell lymphomas

DRUG

Pegfilgrastim

Given IV for supportive care

PROCEDURE

Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computerized tomography (CT)

Undergo imaging

Sponsors & Collaborators

• UC Hematologic Malignancies Consortium (UCHMC)

  collaborator UNKNOWN

• Foresight Diagnostics, Inc.

  collaborator UNKNOWN

• Natera, Inc.

  collaborator INDUSTRY

• Gateway for Cancer Research

  collaborator OTHER

• Michael Spinner, MD

  lead OTHER

Principal Investigators

• Michael Spinner, MD · University of California, San Francisco

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2029-03-31

Completion

2033-10-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations