NCT06745076

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OUTLINE: CYCLES 1-2: Patients receive nivolumab intravenously (IV), doxorubicin IV, vinblastine IV and dacarbazine IV on days 1 and 15 of each cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo measurable residual disease (MRD) testing. Patients who are MRD negative are assigned to Arm I and patients who are MRD positive are assigned to Arm II. ARM I: CYCLES 3-4: Patients receive nivolumab IV, doxorubicin IV, vinblastine IV and dacarbazine IV on days 1 and 15 of each cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression of unacceptable toxicity. CYCLES 5-6: Patients receive nivolumab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. ARM II: CYCLES 3-6: Patients receive nivolumab IV, doxorubicin IV, vinblastine IV and dacarbazine IV on days 1 and 15 of each cycle. Cycles repeat every 28 days for up to 4 additional cycles (total of 6 cycles) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year then periodically for up to 5 years. Patients undergo echocardiography or MUGA scan, position emission tomography (PET)-computed tomography (CT) scan, questionnaire and blood sample collection throughout the study.

Conditions

• Advanced Hodgkin Lymphoma
• Classic Hodgkin Lymphoma
• Lugano Classification Stage III Hodgkin Lymphoma AJCC v8
• Lugano Classification Stage IV Hodgkin Lymphoma AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo CT scan
DRUG	Dacarbazine	Given IV
DRUG	Doxorubicin	Given IV
PROCEDURE	Echocardiography Test	Undergo echocardiography
PROCEDURE	Multigated Acquisition Scan	Undergo MUGA scan
BIOLOGICAL	Nivolumab	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET scan
DRUG	Vinblastine	Given IV
OTHER	Questionnaire	Complete questionnaire

Timeline

• Start date: 2025-03-06
• Primary completion: 2032-01-03
• Completion: 2033-01-03
• First posted: 2024-12-20
• Last updated: 2026-03-05

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study