drugset / Trial / NCT07021989
ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma
Phase 2
Not yet recruiting
38 enrolled
Michael Spinner, MD
Foresight Diagnostics, Inc. · collabGateway for Cancer Research · collabNatera, Inc. · collabUC Hematologic Malignancies Consortium (UCHMC) · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-07-01
- Primary completion
- 2029-05-31
- Completion
- 2033-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 15 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Vinorelbine | Small molecule | 20 mg/m2 | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | Intravenous |