RecruitingPhase 2NCT06745076

Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation for the Treatment of Patients With Advanced Hodgkin Lymphoma

A Multicenter Study PRECISE-HL: Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation in Advanced Hodgkin Lymphoma


Sponsor

University of Washington

Enrollment

125 participants

Start Date

Mar 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well personalized reduction of chemotherapy (nivolumab, doxorubicin, vinblastine and dacarbazine) based on circulating tumor deoxyribonucleic acid (ctDNA) evaluation works for treating patients with Hodgkin lymphoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Chemotherapy drugs, such as nivolumab, doxorubicin, vinblastine and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Many types of tumors tend to lose cells or release different types of cellular products including their DNA, which is referred to as ctDNA, into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids and, based on the result, assign patients to a reduced number of chemotherapy treatments or the standard number of chemotherapy treatments. Using ctDNA to assign a personalized reduction of chemotherapy may be effective in treating patients with advanced Hodgkin lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether tracking tumor DNA fragments in the blood (called ctDNA) during treatment can guide doctors to safely reduce chemotherapy intensity for people with advanced (Stage 3 or 4) Hodgkin lymphoma — potentially reducing side effects while maintaining effectiveness. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with Stage 3 or 4 classical Hodgkin lymphoma and have not yet started systemic treatment - You have measurable disease - You are well enough to receive 6 cycles of chemotherapy including an anthracycline (a type of chemotherapy drug) - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - You have cancer spread to the brain - You have untreated HIV or active hepatitis B or C with a detectable viral load - You are pregnant or breastfeeding - You have another active cancer (except treated skin cancer or cervical carcinoma in situ) - You have significant heart disease (recent heart attack, uncontrolled arrhythmia, or weak heart pumping function) - You currently need supplemental oxygen - You have active autoimmune disease (except vitiligo or controlled thyroid disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT scan

DRUGDacarbazine

Given IV

DRUGDoxorubicin

Given IV

PROCEDUREEchocardiography Test

Undergo echocardiography

PROCEDUREMultigated Acquisition Scan

Undergo MUGA scan

BIOLOGICALNivolumab

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET scan

DRUGVinblastine

Given IV

OTHERQuestionnaire

Complete questionnaire


Locations(5)

City of Hope

Irvine, California, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Washington University in St. Louis

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06745076


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