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

Part of paid clinical trials in Irvine, California.

Sponsor
University of Washington
Study ID
NCT06745076
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 6, 2025
Status verified
Dec 2025
Primary completion
Jan 3, 2032
Completion
Jan 3, 2033

Study Design

Enrollment
125 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (MRD negative)
    CYCLES 1-2: 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 or unacceptable toxicity. Patients then undergo MRD testing. 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. Patients undergo echocardiography or MUGA scan, PET/CT scan, questionnaire and blood sample collection throughout the study.
  • Experimental: Arm II (MRD positive)
    CYCLES 1-2: 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 or unacceptable toxicity. Patients then undergo MRD testing. 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. Patients undergo echocardiography or MUGA scan, PET/CT scan, questionnaire and blood sample collection throughout the study.

Primary Outcome Measure

Progression free survival (PFS) in patients with undetectable minimal residual disease (MRD) after 2 cycles of treatment [ Time Frame: At 1 year ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
City of HopeIrvineCalifornia92618
Azra Borogovac, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Reid Merryman, MD (PRINCIPAL_INVESTIGATOR)
Washington University in St. LouisSt LouisMissouri63110
David Russler-Germain, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Alison Moskowitz, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Hongyan Du, Ph.D.
[email protected]
206-606-1221
Ryan Lynch, MD (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope· Irvine, CADana-Farber Cancer Institute· Boston, MAWashington University in St. Louis· St Louis, MOMemorial Sloan Kettering Cancer Center· New York, NYFred Hutch/University of Washington Cancer Consortium· Seattle, WA

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