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Anti-metabolites
Personalized Chemotherapy for Hodgkin's Lymphoma
Seattle, WA
Phase 2
Recruiting
Led By Ryan Lynch, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be age 18 or older
Patients must be appropriate candidates for 6 cycles of combination chemotherapy including an anthracycline
Must not have
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%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether adjusting chemotherapy based on levels of circulating tumor DNA (ctDNA) can effectively treat patients with advanced Hodgkin lymphoma. By measuring ctDNA levels in the blood, doctors can
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Who is the study for?
This trial is for patients with advanced Hodgkin lymphoma, where the cancer may have spread. Participants should be eligible for chemotherapy and willing to undergo various scans and provide biospecimens. Specific eligibility details are not provided.Check my eligibility
What is being tested?
The study tests personalized chemotherapy reduction based on ctDNA levels in blood. Patients receive nivolumab, doxorubicin, vinblastine, and dacarbazine. The goal is to see if fewer treatments can be as effective when ctDNA levels are low.See study design
What are the potential side effects?
Chemotherapy drugs like those used in this trial can cause side effects such as nausea, fatigue, hair loss, increased risk of infection due to lowered white blood cell counts, heart issues from doxorubicin, and potential nerve damage from vinblastine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am a suitable candidate for a specific 6-cycle chemotherapy that includes an anthracycline.
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My kidney function is within the normal range.
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I do not have active lymphoma in my brain or spinal cord.
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I am able to get out of my bed or chair and move around.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe health issues that would prevent me from receiving strong chemotherapy.
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I do not have recent heart attacks or severe heart failure.
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I have or had lung inflammation that needed steroids.
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I use supplemental oxygen.
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I am not pregnant or nursing and agree to use effective birth control.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (MRD positive)Experimental Treatment10 Interventions
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.
Group II: Arm I (MRD negative)Experimental Treatment10 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vinblastine
1998
Completed Phase 3
~5850
Biospecimen Collection
2004
Completed Phase 3
~1810
Computed Tomography
2017
Completed Phase 2
~2440
Dacarbazine
2005
Completed Phase 3
~5740
Doxorubicin
2012
Completed Phase 3
~8030
Echocardiography
2013
Completed Phase 4
~11580
Multigated Acquisition Scan
2017
Completed Phase 3
~370
Nivolumab
2014
Completed Phase 3
~3880
Positron Emission Tomography
2011
Completed Phase 2
~2230
Find a Location
Closest Location:Fred Hutch/University of Washington Cancer Consortium· Seattle, WA· 1722 miles
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,853 Previous Clinical Trials
2,021,736 Total Patients Enrolled
Ryan Lynch, MDPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
42 Total Patients Enrolled