NCT07021989 · Michael Spinner, MD
ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma
What this study is about
This is a single treatment group$1, where both patients and doctors know the treatment given, conducted at multiple hospitals, 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.
View original scientific description
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.
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
Primary outcome measures
Percentage of participants with a complete response
Time frame: Up to 4 cycles (a cycle is 21 days)
To determine the ctDNA/MRD negative, PET negative complete response rate for cHL, participants undergoing treatment with pembro + GVD will have a composite response incorporating the following two criteria: (1) Absence of detectable cHL ctDNA as assessed by Foresight CLARITY LDT after 2 cycles of treatment and (2) complete response by Fluorodeoxyglucose (FDG) PET/CT, assessed by Lugano criteria after 2 cycles, or 4 if participant demonstrates indeterminate response (IR) after 2 cycles. Lugano classification for response using FDG PET-CT is as follows: A score is given which ranges from 1 (No uptake above background) to 5 (Hottest area of uptake markedly \> liver and/or new lesions present). A CR is defined as a score of 1,2,3 in nodal or extranodal sites with or without a residual mass. Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) will be used to distinguish IR, SD or PD. Response rate will be summarized by percentage, along with 95% confidence intervals.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥ 18 years. 2. Histologically confirmed classic Hodgkin lymphoma (including nodular sclerosis, lymphocyte-rich, mixed cellularity, and lymphocyte-depleted Hodgkin lymphoma). 3. Participants must have relapsed or refractory disease after no more than one line of systemic therapy. First line therapy must have included doxorubicin. 4. 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. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky ≥ 50%). 6. Demonstrates adequate organ function as defined below: 1. Absolute neutrophil count (ANC) ≥ 1.0 X 10\^9/ L (1000/microliter (mcL), growth factors permitted). 2. Platelets ≥ 75 X 10\^9 / L (75,000/mcL, platelet transfusion independent). 3. Total bilirubin ≤ 1.5 x institutional upper limit of normal, unless elevated due to Gilbert's syndrome. 4. Aspartate aminotransferase (AST) / (S
Where
- Davis, California
- Fresno, California
- Irvine, California
- La Jolla, California
- Los Angeles, California
- San Francisco, California
Collaborators
UC Hematologic Malignancies Consortium (UCHMC), Foresight Diagnostics, Inc., Natera, Inc., Gateway for Cancer Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2026 · Source of record for eligibility and locations