Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Fresno, California and other locations
Dates
study started
study ends around
Principal Investigator
by Michael Spinner, MD

Description

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.

Official Title

Pembrolizumab and GVD With ctDNA-guided Consolidation in Patients With Relapsed or Refractory Classic Hodgkin Lymphoma: A Multicenter Phase 2 Study of the University of California Hematologic Malignancies Consortium

Details

Keywords

Hodgkin Lymphoma, Adult, Refractory Hodgkin Lymphoma, Classic Hodgkin Lymphoma, circulating tumor DNA, Lymphoma, Hodgkin Disease, Gemcitabine, Pembrolizumab, Doxorubicin, Liposomal doxorubicin, Vinorelbine, Fluorodeoxyglucose F18, Non-investigational, involved site radiotherapy (ISRT), Foresight CLARITY™ LDT, Pegfilgrastim, Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computerized tomography (CT)

Eligibility

Locations

  • UCSF-Fresno
    Fresno California 93701 United States
  • UCSF
    San Francisco California 94143 United States

Lead Scientist at UCSF

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Michael Spinner, MD
ID
NCT07021989
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 38 study participants
Last Updated