Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy portion, which attempts to destroy the cell.

The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you will receive in this research study are approved for use in people with Hodgkin Lymphoma. A drug called bleomycin is usually included with AVD, but since it appears to be a less effective drug with significant potential risks, it is being replaced in this study with the drug brentuximab.

In this research study, the investigators are looking to see whether brentuximab in combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Dana-Farber Cancer Institute; H. Lee Moffitt Cancer Center and Research Institute; Seagen Inc.; Seattle Genetics, Inc.
• Treatments: Antibodies, Monoclonal; Brentuximab Vedotin; Dacarbazine; Doxorubicin; Liposomal doxorubicin; Vinblastine

Criteria

Inclusion Criteria:

• Previously untreated stage IA, IB, IIA or IIB classical Hodgkin Lymphoma

• Non-bulky disease defined as less than 10 cm in maximal diameter

• Measurable disease greater than or equal to 1.5 cm

• ECOG performance status of 0 or 2

• Willing to use 2 effective forms of birth control

Exclusion Criteria:

• No prior chemotherapy or radiotherapy for Hodgkin lymphoma

• Not receiving any other investigational agents

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to Adriamycin, Vinblastine, Dacarbazine or brentuximab

• No pre-existing grade 3 or greater neuropathy

• No uncontrolled intercurrent illness

• Not pregnant or breastfeeding

• No history of a different malignancy unless disease free for at least one year