ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma

Part of paid clinical trials in Davis, California.

Sponsor
Michael Spinner, MD
Study ID
NCT07021989
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Given intravenously
  • Non-investigational, involved site radiotherapy (ISRT) — RADIATION
    Undergo possible, standard of care, non-investigational radiation therapy
  • Gemcitabine — DRUG
    Given IV
  • Vinorelbine — DRUG
    Given IV
  • Liposomal Doxorubicin — DRUG
    Given IV
  • Foresight CLARITY™ LDT — DEVICE
    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
  • Pegfilgrastim — DRUG
    Given IV for supportive care
  • Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computerized tomography (CT) — PROCEDURE
    Undergo imaging

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
May 31, 2029
Completion
Dec 31, 2033

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Pembrolizumab + GVD)
    All participants receive 2, 21-day cycles of 200 mg Pembrolizumab (pembro) on day 1 of each cycle (pembro) and 1000mg Gemcitabine, 20mg/m\^2 of Vinorelbine, Liposomal doxorubicin 15 mg/m2 (GVD) on days 1 and 8 of each cycle for up to 2 cycles. Pegfilgrastim is administered on day 8 or 9 of each cycle. FDG-PET/CT imaging and Foresight CLARITY LDT ctDNA response after 2 cycles will determine if participants are eligible for an additional 2 cycles of pembro + GVD or salvage therapy and ASCT. Participants may be able to qualify for consolidation without ASCT (pembro and/or 30 Gy ISRT) depending on response. Radiographic response after 4 cycles will be conducted to determine eligibility for consolidation without ASCT for participants with CR or standard of care salvage therapy and ASCT, for participants with partial response (PR), stable disease (SD), or progressive disease (PD) after a second administration of pembro+GVD. Participants are followed for up to 5 years.

Primary Outcome Measure

Percentage of participants with a complete response [ Time Frame: Up to 4 cycles (a cycle is 21 days) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of California DavisDavisCalifornia95616-
University of California San Francisco-FresnoFresnoCalifornia93701-
University of California IrvineIrvineCalifornia92617-
University of California, San DiegoLa JollaCalifornia92093-
Unversity of California, Los AngelesLos AngelesCalifornia90095-
University of California, San FranciscoSan FranciscoCalifornia94143
UCSF Hematopoietic Malignancies Clinical Trial Recruitment
[email protected]
877-827-3222
Nickole Criner
[email protected]
Michael Spinner, MD (PRINCIPAL_INVESTIGATOR)

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