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.
Additional locations may be listed on ClinicalTrials.gov for NCT06745076.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Active
Contact: Hongyan Du
Phone: 206-606-1221
PRIMARY OBJECTIVE:
I. To assess progression free survival at 1 year in patients with undetectable minimal residual disease (MRD) after 2 cycles of nivolumab, doxorubicin, vinblastine, and dacarbazine who receive nivolumab alone for cycle 5 and 6 of treatment.
SECONDARY OBJECTIVES:
I. To assess the 1 year progression free survival in the overall study population as well as patients with detectable MRD at 1 year.
II. To assess 2-year progression free survival in the overall cohort as well as stratified by MRD status after cycle 2.
III. To assess best overall response, as well as to assess complete response as best response.
TERTIARY/EXPLORATORY OBJECTIVES:
I. To assess the duration of response, MRD rates at other time points including end of treatment, safety, outcomes by molecular genotype and other biomarkers.
II. To assess change in quality of life by validated tools between the 2 treatment arms.
III. To compare the performance of position emission tomography (PET)-computed tomography (CT) after 2 cycles with ctDNA in predicting relapse in MRD-positive and MRD-negative cohorts.
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 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.
Patients undergo echocardiography or multigated acquisition scan (MUGA), PET/CT scan, questionnaire and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 3 months for 1 year then periodically for up to 5 years.
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorRyan Lynch
