Blood test may guide safer chemo for hodgkin lymphoma patients
NCT ID NCT06745076
First seen Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 9 times
Summary
This phase 2 trial is testing whether a blood test that measures tumor DNA (ctDNA) can help doctors safely reduce the amount of chemotherapy for people with advanced Hodgkin lymphoma. After two cycles of standard chemo, patients with undetectable ctDNA may receive fewer total cycles, while those with detectable ctDNA continue standard treatment. The goal is to maintain effectiveness while minimizing side effects from chemotherapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab, doxorubicin, vinblastine, dacarbazine
- What this could lead to
- If successful, this approach could allow many patients with advanced Hodgkin lymphoma to receive fewer chemotherapy cycles without compromising cancer control, reducing side effects.
- What could go wrong
- This is a phase 2 trial with only 125 participants, so results are preliminary. The ctDNA-guided reduction may not work for everyone, and some patients might still need full chemotherapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 125 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jan 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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City of Hope
RECRUITINGIrvine, California, 92618, United States
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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Fred Hutch/University of Washington Cancer Consortium
RECRUITINGSeattle, Washington, 98109, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Stanford Cancer Institute Palo Alto
RECRUITINGPalo Alto, California, 94304, United States
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Washington University in St. Louis
RECRUITINGSt Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can early PET scans guide a gentler, more effective attack on hodgkin lymphoma?
- Immune booster before chemo may shrink hodgkin tumors with fewer drugs
- Immune booster may strengthen stem cell transplant against hodgkin lymphoma
- Two-Drug combo aims to outsmart resistant hodgkin lymphoma
- Brain fog after lymphoma: study probes lasting cognitive effects of chemotherapy
- Can an old drug make immunotherapy work again for hodgkin lymphoma?