About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT scan
Dacarbazine
DrugGiven IV
Doxorubicin
DrugGiven IV
Echocardiography Test
Procedure/SurgeryUndergo echocardiography
Multigated Acquisition Scan
Procedure/SurgeryUndergo MUGA scan
Nivolumab
Biological/VaccineGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET scan
Vinblastine
DrugGiven IV
Questionnaire
Other interventionComplete questionnaire
Treatment groups
Trial outcomes
Primary outcomes
Progression free survival (PFS) in patients with undetectable minimal residual disease (MRD) after 2 cycles of treatment
Secondary outcomes
PFS in MRD positive patients after 2 cycles of treatment
PFS in the overall cohort
Best response
Sponsors and contacts
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