ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma
This study is for adults with Hodgkin lymphoma that has returned or not responded to previous treatment. It is testing a combination of medicines: pembrolizumab, gemcitabine, vinorelbine, and liposomal doxorubicin. Some participants might also receive standard radiation therapy. Researchers will use a special blood test called circulating tumor DNA (ctDNA) to see how well the treatment is working. The main goal is to see how many participants have a complete response (meaning the cancer is no longer detectable) after up to four cycles of treatment. You must be at least 18 years old and have received doxorubicin as part of your first treatment. The current recruitment status is unclear.
- Study design
- This is a single-arm, open-label study, meaning all 38 participants will receive the same treatment and everyone involved will know which treatments are given.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will follow participants to measure progression-free survival and overall survival at 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma
At a glance
Conditions
Where it's being run
6 sites across 1 statesStudy leadership
- Michael Spinner, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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What this trial measures
- Percentage of participants with a complete responseUp 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.