This phase II trial studies how well giving brentuximab vedotin together with combination chemotherapy works in treating older patients with previously untreated stage II-IV Hodgkin lymphoma (HL). Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine, and dacarbazine (AVD), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving brentuximab vedotin, doxorubicin hydrochloride, vinblastine, and dacarbazine together may kill more cancer cells.
LEAD IN: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Given IV
Given IV
Given IV
Given IV
Ancillary studies
Optional correlative studies
Optional correlative studies
Correlative studies
Correlative studies
Optional correlative studies
Optional correlative studies
Optional correlative studies
Stanford University Medical Center
Stanford, California, United States
NorthwesternU
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Memorial Sloan- Kettering Cancer Center
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Overall response rate after chemotherapy
The primary objective of this study is to assess the overall response rate among older patients with HL receiving sequential brentuximab vedotin therapy with AVD chemotherapy
Time frame: 2 years
Overall response rate
Overall response rate progression-free survival (PFS), time to treatment failure (TTF), freedom from progression (FFP), and overall survival (OS) rates following SGN-35/AVD sequential therapy.
Time frame: Baseline, every 3 weeks during the first 2 cycles, every 2 weeks during next 6 cycles, every 4 weeks furing the last 4 cycles, and then every 3 months for up to 3 years from entering the study
Overall response rate based on best response (CR and PR) and the tumor local control rate (CR, PR, and stable disease [SD])
Estimates of response rate based on best response (CR and PR) and the tumor local control rate (CR, PR, and stable disease \[SD\])
Time frame: Baseline, every 3 weeks during the first 2 cycles, every 2 weeks during next 6 cycles, every 4 weeks furing the last 4 cycles, and then every 3 months for up to 3 years from entering the study
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