This phase II trial studies how well brentuximab vedotin, doxorubicin hydrochloride, and dacarbazine work in treating patients with stage I-IIB non-bulky Hodgkin lymphoma. Brentuximab vedotin may interfere with the ability of cancer cells to grow and spread by binding to a protein on the surface of cancer cells and then releasing a cancer-killing substance to them. Drugs used in chemotherapy, such as doxorubicin hydrochloride and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin together with doxorubicin hydrochloride and dacarbazine may kill more cancer cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02505269.
PRIMARY OBJECTIVE:
I. To investigate the clinical activity of brentuximab (brentuximab vedotin) with Adriamycin (doxorubicin hydrochloride) and dacarbazine (AD) in untreated non-bulky stage I and II classical Hodgkin lymphoma (cHL).
SECONDARY OBJECTIVE:
I. To describe the safety and tolerability of brentuximab combined with AD in previously untreated non-bulky limited stage cHL.
OUTLINE:
Patients receive brentuximab vedotin intravenously (IV) over 30 minutes, doxorubicin hydrochloride IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) may receive an additional 2 cycles of treatment and patients achieving stable disease (SD) or partial response (PR) may receive 4 additional cycles of treatment.
After completion of study treatment, patients are followed up every 3-6 months for 2 years, every 6 months for 2 years, and then at least every 12 months thereafter.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorJeremy S. Abramson
