Skip to main content

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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment125 people
  • Recruiting US sites6
  • SponsorUniversity of Washington
  • RegistryNCT06745076

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation for the Treatment of Patients With Advanced Hodgkin Lymphoma: a one-minute explainerNCT067450761 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • Classical Hodgkin lymphoma without prior systemic therapy, stage 3 or 4. Corticosteroids for symptom relief are allowed
  • Measurable disease per Lugano criteria
  • Patients must be 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 and/or transfusion support is permissible to stabilize participant prior to study treatment if needed. There is no lower limit to cytopenias if related to bone marrow involvement or underlying Hodgkin lymphoma
  • Platelets ≥ 50,000/mm^3 (without transfusion or growth factor support). Growth factor and/or transfusion support is permissible to stabilize participant prior to study treatment if needed. There is no lower limit to cytopenias if related to bone marrow involvement or underlying Hodgkin lymphoma
  • Hemoglobin ≥ 8 g/dL. Growth factor and/or transfusion support is permissible to stabilize participant prior to study treatment if needed. There is no lower limit to cytopenias if related to bone marrow involvement or underlying Hodgkin lymphoma
  • Serum creatinine < 1.5 x upper limits of normal (ULN) or creatinine clearance greater than 30/ml per minute by Cockcroft Gault formula
  • Total bilirubin ≤ 1.5 times upper limit of normal OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 × ULN). Patients with Gilbert Syndrome and direct bilirubin < 1.5 x ULN or confirmatory UGT1A1 testing are allowed to enroll
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal (≤ 5 × ULN for participants with liver involvement)
  • Patients must be age 18 or older
  • All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
  • Patients must be anticipated to complete all planned study therapy
  • Male patients who are not surgically sterile, including those who have not undergone vasectomy with documented azoospermia or other confirmed sterilization, and who have a partner of childbearing potential must agree that they and/or their partner will use effective contraception beginning with the first dose of study therapy and continuing through 120 days after the last dose of study therapy. Acceptable methods include participant use of barrier contraception and/or partner use of a highly effective contraceptive method, including an intrauterine device or system, hormonal implant, bilateral tubal occlusion, or other methods considered highly effective according to institutional standards. Partners who are not of childbearing potential, including those who are surgically sterile or postmenopausal, do not necessitate contraception by the participant for pregnancy prevention
  • Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Patients with recent fertility preservation may falsely test human chorionic gonadotropin (HCG) positive, and may be allowed on study with principal investigator (PI) approval
  • Female patients of childbearing potential must agree to use effective contraception or abstain from heterosexual activity beginning with the first dose of study therapy and continuing through 120 days after the last dose of study medication. Acceptable methods include two methods of birth control, one of which may be a barrier method, or a highly effective contraceptive method such as an intrauterine device or system, hormonal implant, bilateral tubal occlusion, or other methods considered highly effective according to institutional standards. Female patients are considered not of childbearing potential if they have been surgically sterilized or have been free from menses for more than 1 year

You cannot join if

  • Patients known positive for HIV or infectious hepatitis type B or C with a detectable viral load may not participate. Hepatitis B/C, and HIV testing are not required at screening unless mandated by local health authority.
  • Patients living with HIV, on anti-viral treatment and undetectable viral load are allowed
  • Patients with positive hepatitis (hep) B core antibody are allowed on study with an undetectable viral load and appropriate prophylaxis
  • Patients with positive hepatitis C antibody are allowed with undetectable viral load
  • Pregnant or nursing women. Men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
  • Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 2 years or greater, unless approved by the principal investigator
  • Patients who have other medical conditions that would contraindicate treatment with aggressive chemotherapy (including active infection, uncontrolled hypertension, congestive heart failure, unstable angina pectoris, or myocardial infarction within the past 6 months, uncontrolled arrhythmia, severe pulmonary disease or requirement of supplemental oxygen)
  • Active ischemic heart disease (eg. myocardial infarction within 6 months) or congestive heart failure (eg. left ventricular ejection fraction < 50%)
  • Concurrent use of other anti-cancer agents or experimental treatments
  • Known current or prior autoimmune disease with the exception of vitiligo. Patients with a history of autoimmune thyroid disease on a stable dose of thyroid hormone are also allowed
  • Active or prior history of pneumonitis/interstitial lung disease that required corticosteroids
  • Current use of supplemental oxygen
  • Is known to have received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of trial treatment. Other non-live or live-attenuated vaccines (eg. COVID, Influenza) are allowed

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

nivolumab. A fully human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed death-1 (PD-1, PCD-1) with immune checkpoint inhibitory and antineoplastic activities. Upon administration, nivolumab binds to and blocks the activation of PD-1, an immunoglobulin superfamily (IgSF) transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), which is overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on antigen-presenting cells (APCs). This results in the activation of T cells and cell-mediated immune responses against tumor cells. Activated PD-1 negatively regulates T-cell activation and plays a key role in tumor evasion from host immunity. NCI Drug Dictionary

Treatments listed in the registry

  • 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

The study

Treatment groups

Non Randomized · Parallel · masking: None

Arm I (MRD negative) (Experimental)

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.

Arm II (MRD positive) (Experimental)

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.

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • blood samples: Part of the study plan
  • CT scans: Part of the study plan
  • PET scans: Part of the study plan
  • echocardiogram: Part of the study plan
  • questionnaires: Part of the study plan

Goals

What the study measures

Main goals

  • Progression free survival (PFS) in patients with undetectable minimal residual disease (MRD) after 2 cycles of treatment (At 1 year)

Other goals

  • PFS in MRD positive patients after 2 cycles of treatment
  • PFS in the overall cohort
  • Best response

Planned enrollment: 125 (estimated).

Where

Recruiting US sites

  • City of Hope, Irvine, California
  • Stanford Cancer Institute Palo Alto, Palo Alto, California
  • Dana-Farber Cancer Institute, Boston, Massachusetts
  • Washington University in St. Louis, St Louis, Missouri
  • Memorial Sloan Kettering Cancer Center, New York, New York
  • Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 8, 2026. Public record; not medical advice.

For you, or someone you love

Whether or not this trial is the one, bring AI into your corner.

A complex diagnosis brings new questions every week, in a trial and out of one. Triangle keeps your whole medical file together, reads it with you in plain language, and helps you and your family decide what to ask next.

Start your 7-day free trial

Then $9 a month. Cancel anytime.

  • Every record in one place

    Requested from your hospitals and clinics through the national networks. Add scans, pathology and anything on paper.

  • Read in plain words

    Reports explained as they come in, with lab values you can follow before treatment, during a trial and after.

  • Ready for every appointment

    Ask about your own file, and walk in with questions for your oncologist or the trial team.

  • Your people, in the loop

    Share one profile with the family helping you, and with your doctors.

Members also get a deeper analysis of their records and any sequencing data, including clinical trials that may fit, reviewed by a licensed physician before they receive it.

Already in a trial?

It turns into a project to manage: visits, scans, labs, side effects and paperwork. Triangle keeps it organized in one place for you or for whoever's helping.

Organize my trial

7-day free trial, then $9 a month. Cancel anytime.