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
408 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Classical Hodgkin lymphoma without prior systemic therapy, stage 3 or 4. Corticosteroids for symptom relief are allowed
- Measurable disease per Lugano criteria
- Appropriate candidates for 6 cycles of combination chemotherapy including an anthracycline
- No evidence of active central nervous system lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) ≥ 500/mm^3; growth factor or transfusion support allowed if needed
- Platelets ≥ 50,000/mm^3 without transfusion or growth factor support; support allowed if needed
- Hemoglobin ≥ 8 g/dL; support allowed if needed
- Serum creatinine < 1.5 x upper limits of normal (ULN) or creatinine clearance > 30/ml per minute
- Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for elevated total bilirubin; Gilbert Syndrome allowed with testing
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN with liver involvement)
- Age 18 years or older
- Informed consent given according to guidelines
- Anticipated 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 willing to use two birth control methods, be surgically sterile, or abstain during study through 120 days after last dose
You will not qualify if you...
- Positive for HIV or hepatitis B or C with detectable viral load (patients with undetectable viral load on treatment allowed)
- Pregnant or nursing women
- Prior malignancies except treated basal cell carcinoma, squamous cell carcinoma of skin, breast or cervical cancer in situ, or other cancers disease-free for 2+ years unless approved
- Medical conditions contraindicating aggressive chemotherapy (active infection, uncontrolled hypertension, heart failure, unstable angina or recent myocardial infarction, uncontrolled arrhythmia, severe pulmonary disease, oxygen requirement)
- Active ischemic heart disease or left ventricular ejection fraction < 50%
- Use of other anti-cancer agents or experimental treatments
- Known autoimmune disease except vitiligo; stable autoimmune thyroid disease allowed
- History of pneumonitis or interstitial lung disease requiring corticosteroids
- Current use of supplemental oxygen
- Receipt of live vaccine within 30 days prior to first dose (non-live vaccines allowed)
AI-Screening
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Complete this quick 3-step screening to check your eligibility
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.
CONTACT
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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