Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma

Status: Recruiting
Phase: Phase 2
Diagnosis: Hodgkin's Lymphoma
NCT ID: NCT01534078 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-462

 

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.

 

Conducting Institutions:
Beth-Israel Deaconess Medical Center, Massachusetts General Hospital, Dana-Farber Cancer Institute

Overall PI:
Jeremy Abramson, MD, Massachusetts General Hospital

Site-responsible Investigators:
Jon Arnason, MD, Beth Israel Deaconess Medical Center
Ann LaCasce, MD, Dana-Farber Cancer Institute

Contacts:
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Kathleen McDermott, kmcdermott@partners.org

Eligibility 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
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