Clinical trial Recruiting at 6 sites Phase 2 Interventional Ages 18 and up

Personalized chemotherapy reduction for advanced Hodgkin lymphoma

Official title: A Multicenter Study PRECISE-HL: Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation in Advanced Hodgkin Lymphoma

Run by University of Washington · NCT06745076 · Data updated 2026-11-12

This study is testing if people with advanced Hodgkin lymphoma can safely get fewer rounds of personalized chemotherapy based on their tumor DNA levels while still effectively treating their cancer.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment125 (estimated)
SponsorUniversity of Washington
Academic / other
Drugs / interventionschemotherapy, nivolumab, doxorubicin
Locations6 sites (Irvine, California and 5 other locations)
StatusRecruiting
StartedMarch 6, 2025
Main results expectedJanuary 3, 2032
Study endsJanuary 3, 2033
Registry record updatedSeptember 9, 2026
Trial IDNCT06745076 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals with classical Hodgkin lymphoma at stage 3 or 4 who have not received prior systemic therapy.

Probably not a fit

Patients with active central nervous system lymphoma or those who have previously undergone systemic therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the effectiveness of personalized chemotherapy intensity reduction based on circulating tumor DNA (ctDNA) levels in patients with advanced Hodgkin lymphoma. Participants receive a combination of nivolumab, doxorubicin, vinblastine, and dacarbazine, with treatment adjustments made according to ctDNA evaluation results. The study aims to determine if patients with lower ctDNA levels can safely receive fewer chemotherapy cycles while maintaining treatment efficacy. Patients are monitored for disease progression and toxicity throughout the treatment period.

Why it matters

Potential benefit: If successful, this approach could lead to less intensive chemotherapy regimens for patients, reducing side effects while maintaining treatment effectiveness.

How similar studies have gone: Other studies have shown promise in using ctDNA for treatment personalization, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

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

Study contacts

  • Principal investigator: Ryan Lynch, MD — Fred Hutch/University of Washington Cancer Consortium
  • Study coordinator: Hongyan Du, Ph.D.
  • Email: hongydu@fredhutch.org
  • Phone: 206.606.1221

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.