Advanced Hodgkin LymphomaPhase 2NCT06745076
Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation for the Treatment of Patients With Advanced Hodgkin Lymphoma
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Dacarbazine in people with Advanced Hodgkin Lymphoma and Classic Hodgkin Lymphoma, run by University of Washington at 6 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hodgkin Lymphoma, Classic Hodgkin Lymphoma, Lugano Classification Stage III Hodgkin Lymphoma AJCC v8
- What is being tested?
- Biospecimen Collection, Computed Tomography and Dacarbazine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 6 sitesUnited States
- Study dates
- 6 Mar 2025to 3 Jan 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Reid Merryman, MD
- Recruiting
City of Hope
Irvine, California, 92618
Azra Borogovac, MD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Alison Moskowitz, MD
- Recruiting
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
Joseph Schroers-Martin, MD
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Hongyan Du, Ph.D., 206-606-1221, hongydu@fredhutch.org
Ryan Lynch, MD
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
David Russler-Germain, MD
About this study
Official title: A Multicenter Study PRECISE-HL: Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation in Advanced Hodgkin Lymphoma
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.
Read the detailed description
OUTLINE:
CYCLES 1-2: Patients receive nivolumab intravenously (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 measurable residual disease (MRD) testing.
Patients who are MRD negative are assigned to Arm I and patients who are MRD positive are assigned to Arm II.
ARM I:
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.
ARM II:
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.
After completion of study treatment, patients are followed up every 3 months for 1 year then periodically for up to 5 years.
Patients undergo echocardiography or MUGA scan, position emission tomography (PET)-computed tomography (CT) scan, questionnaire and blood sample collection throughout the study.
- Conditions
- Advanced Hodgkin Lymphoma, Classic Hodgkin Lymphoma, Lugano Classification Stage III Hodgkin Lymphoma AJCC v8, Lugano Classification Stage IV Hodgkin Lymphoma AJCC v8
- Being tested
- Biospecimen Collection, Computed Tomography, Dacarbazine, Doxorubicin, Echocardiography Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT scan
DacarbazineDrug
Also called 4-(Dimethyltriazeno)imidazole-5-carboxamide, 5-(Dimethyltriazeno)imidazole-4-carboxamide, Asercit, Biocarbazine
Given IV
DoxorubicinDrug
Also called Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin
Given IV
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo echocardiography
Multigated Acquisition ScanProcedure or surgery
Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan
Undergo MUGA scan
NivolumabBiological
Also called ABP 206, BCD-263, BMS 936558, BMS-936558
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET scan
VinblastineDrug
Also called Vincaleucoblastine, VLB
Given IV
QuestionnaireOther
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Dacarbazine; Drug: Doxorubicin; Procedure: Echocardiography Test; Procedure: Multigated Acquisition Scan; Biological: Nivolumab; Procedure: Positron Emission Tomography; Drug: Vinblastine; Other: Questionnaire |
| 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. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Dacarbazine; Drug: Doxorubicin; Procedure: Echocardiography Test; Procedure: Multigated Acquisition Scan; Biological: Nivolumab; Procedure: Positron Emission Tomography; Drug: Vinblastine; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) in patients with undetectable minimal residual disease (MRD) after 2 cycles of treatment
Measured: At 1 year
Secondary outcomes (3)
PFS in MRD positive patients after 2 cycles of treatment
Measured: At 1 year
PFS in the overall cohort
Measured: At 2 years
Best response
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start6 Mar 2025
- Primary completion3 Jan 2032 (estimated)
- Study completion3 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Lynch, MD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745076
- Sponsor's protocol ID
- RG1124935
- Other IDs
- NCI-2024-09815, 20689
- Status last verified
- Sep 2026
- First submitted
- 13 Dec 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study PRECISE-HL: Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation in Advanced Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06745076
- Acronym / sponsor ID
- RG1124935
- Conditions
- Advanced Hodgkin Lymphoma, Classic Hodgkin Lymphoma, Lugano Classification Stage III Hodgkin Lymphoma AJCC v8, Lugano Classification Stage IV Hodgkin Lymphoma AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 3 Jan 2032 (estimated)
- Study completion
- 3 Jan 2033 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OUTLINE:
CYCLES 1-2: Patients receive nivolumab intravenously (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 measurable residual disease (MRD) testing.
Patients who are MRD negative are assigned to Arm I and patients who are MRD positive are assigned to Arm II.
ARM I:
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.
ARM II:
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.
After completion of study treatment, patients are followed up every 3 months for 1 year then periodically for up to 5 years.
Patients undergo echocardiography or MUGA scan, position emission tomography (PET)-computed tomography (CT) scan, questionnaire and blood sample collection throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (MRD negative) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Dacarbazine, Drug: Doxorubicin, Procedure: Echocardiography Test, Procedure: Multigated Acquisition Scan, Biological: Nivolumab, Procedure: Positron Emission Tomography, Drug: Vinblastine, Other: QuestionnaireCYCLES 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 | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Dacarbazine, Drug: Doxorubicin, Procedure: Echocardiography Test, Procedure: Multigated Acquisition Scan, Biological: Nivolumab, Procedure: Positron Emission Tomography, Drug: Vinblastine, Other: QuestionnaireCYCLES 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm I (MRD negative), Arm II (MRD positive) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT scan | Procedure or surgery | Arm I (MRD negative), Arm II (MRD positive) |
| DacarbazineAlso: 4-(Dimethyltriazeno)imidazole-5-carboxamide, 5-(Dimethyltriazeno)imidazole-4-carboxamide, Asercit, BiocarbazineGiven IV | Drug | Arm I (MRD negative), Arm II (MRD positive) |
| DoxorubicinAlso: Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, HydroxyldaunorubicinGiven IV | Drug | Arm I (MRD negative), Arm II (MRD positive) |
| Echocardiography TestAlso: EC, EchocardiographyUndergo echocardiography | Procedure or surgery | Arm I (MRD negative), Arm II (MRD positive) |
| Multigated Acquisition ScanAlso: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool ScanUndergo MUGA scan | Procedure or surgery | Arm I (MRD negative), Arm II (MRD positive) |
| NivolumabAlso: ABP 206, BCD-263, BMS 936558, BMS-936558Given IV | Biological | Arm I (MRD negative), Arm II (MRD positive) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET scan | Procedure or surgery | Arm I (MRD negative), Arm II (MRD positive) |
| VinblastineAlso: Vincaleucoblastine, VLBGiven IV | Drug | Arm I (MRD negative), Arm II (MRD positive) |
| QuestionnaireComplete questionnaire | Other | Arm I (MRD negative), Arm II (MRD positive) |
Primary outcome
Progression free survival (PFS) in patients with undetectable minimal residual disease (MRD) after 2 cycles of treatment
Time frame: At 1 year
3 secondary outcomes
PFS in MRD positive patients after 2 cycles of treatment
Time frame: At 1 year
PFS in the overall cohort
Time frame: At 2 years
Best response
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Lynch, MD principal investigator
Fred Hutch/University of Washington Cancer Consortium
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Dacarbazine in people with Advanced Hodgkin Lymphoma and Classic Hodgkin Lymphoma, run by University of Washington at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongyan Du, Ph.D. (206.606.1221, hongydu@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) in patients with undetectable minimal residual disease (MRD) after 2 cycles of treatment (time frame: At 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.