Actively Recruiting
Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation for the Treatment of Patients With Advanced Hodgkin Lymphoma
Led by University of Washington · Updated on 2026-03-05
125
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a personalized approach to reduce chemotherapy intensity based on circulating tumor DNA (ctDNA) levels in patients with advanced Hodgkin lymphoma. This phase II study aims to see if adjusting chemotherapy using ctDNA evaluation can effectively treat patients whose cancer may have spread to nearby tissues or distant body parts. The chemotherapy includes nivolumab, doxorubicin, vinblastine, and dacarbazine, which work in different ways to stop tumor growth. Participants receive two initial cycles of chemotherapy with all four drugs given intravenously on days 1 and 15 of each 28-day cycle. After these cycles, patients undergo measurable residual disease (MRD) testing. Those who are MRD negative continue with two more cycles of the four-drug chemotherapy followed by two cycles of nivolumab alone. Patients who are MRD positive receive four additional cycles of the full chemotherapy regimen. Treatment continues unless disease progression or unacceptable side effects occur. Throughout the study, participants have regular scans including echocardiography or MUGA, PET/CT scans, blood sample collections, and complete questionnaires. After completing treatment, patients are followed every three months for one year and then periodically for up to five years. The main outcome measured is progression-free survival at one year for patients who are MRD negative after two cycles. Safety, response, and longer-term outcomes are also monitored.
CONDITIONS
Brief Title
Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation for the Treatment of Patients With Advanced Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Classical Hodgkin lymphoma, stage 3 or 4, without prior systemic therapy
- Measurable disease according to Lugano criteria
- Suitable candidates for 6 cycles of combination chemotherapy including an anthracycline
- No active central nervous system lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Absolute neutrophil count of at least 500/mm³ (support allowed if related to lymphoma)
- Platelet count of at least 50,000/mm³ without transfusion or growth factor support
- Hemoglobin level of at least 8 g/dL (support allowed if related to lymphoma)
- Serum creatinine less than 1.5 times upper limit of normal or creatinine clearance over 30 ml/min
- Total bilirubin less than or equal to 1.5 times upper limit of normal or direct bilirubin within normal limits
- AST and ALT less than or equal to 2.5 times upper limit of normal (up to 5 times if liver involved)
- Informed written consent given
- Anticipated ability to complete all planned study therapy
- Male patients agree to use barrier contraception from first dose through 120 days after last dose
- Female patients of childbearing potential have negative pregnancy test within 72 hours before first dose
- Female patients of childbearing potential agree to use two forms of birth control or be sterile or abstain during study and 120 days after last dose
You will not qualify if you...
- Known positive for HIV or hepatitis B or C with detectable viral load (except well-controlled cases as specified)
- Pregnant or breastfeeding women
- History of other malignancies except treated skin cancers or cancers disease-free for 2 years
- Medical conditions contraindicating aggressive chemotherapy such as active infection, uncontrolled heart or lung conditions
- Active ischemic heart disease or congestive heart failure with low heart function
- Use of other anti-cancer or experimental treatments
- Current or prior autoimmune disease except vitiligo or stable autoimmune thyroid disease
- History of pneumonitis or interstitial lung disease requiring corticosteroids
- Current use of supplemental oxygen
- Receipt of live or live-attenuated vaccine within 30 days before first dose (other vaccines allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each, depending on MRD results
Participants receive combination chemotherapy with nivolumab, doxorubicin, vinblastine, and dacarbazine on days 1 and 15 of each 28-day cycle for the first 2 cycles. After MRD testing, treatment continues based on results: MRD negative participants receive 2 more cycles of the combination chemotherapy followed by 2 cycles of nivolumab alone; MRD positive participants receive up to 4 additional cycles of combination chemotherapy. Participants undergo echocardiography or MUGA scan, PET/CT scan, questionnaires, and blood sample collections throughout treatment.
2 visits per 28-day cycle (days 1 and 15)
Duration - Up to 5 years
After completing study treatment, participants are followed up every 3 months for 1 year, then periodically for up to 5 years to monitor health and disease status.
Visits every 3 months for 1 year, then less frequent visits up to 5 years
Trial Site Locations
Total: 5 locations
1
City of Hope
Irvine, California, United States, 92618
Not Yet Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
3
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
5
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
H
Hongyan Du, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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