Limited stage Hodgkin lymphoma is a highly curable disease, but standard treatment with ABVD chemotherapy and radiation can lead to late risks of secondary cancers, lung injury, heart injury, and others. This trial eliminates radiation therapy and reduces intensity of chemotherapy by incorporating the highly active FDA-approved targeted therapy brentuximab vedotin, an antibody-drug conjugate specifically against the lymphoma cells, combined with the standard chemotherapy drugs Adriamycin and Dacarbazine (AD).
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved brentuximab vedotin (brentuximab) as part of the initial treatment of Hodgkin lymphoma. Currently, brentuximab is FDA-approved for treatment of relapsed Hodgkin lymphoma. * Brentuximab works by binding specifically to Hodgkin lymphoma cells, entering the cells, and then releasing the drug to destroy the cell. * The chemotherapy drugs Adriamycin and Dacarbazine (AD) which which participants will receive in this research study are approved for use in people with Hodgkin Lymphoma. * Patients will not receive planned radiation therapy, or the drugs bleomycin or vinblastine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Complete Response Rate
The number of patients that achieved a complete response (CR) to therapy as assessed by the revised International Working Group Criteria. Complete response: * Lymph nodes and extralymphatic sites: Score 1, 2, or 3 with or without a residual mass on 5-point (Daeuville) scale * Bone Marrow: No evidence of FDG-avi disease * No new lesions Deauville Criteria for PET scan Interpretation in Lymphoma Five-point scale: 1. No Uptake 2. Uptake ≤ mediastinum 3. Uptake \>mediastinum but ≤ liver 4. Uptake moderately increased compared to liver at any site 5. Uptake markedly increased compared to the liver at any site or/and new sites of disease
Time frame: 4-6 months
Overall Response Rate
The number of patients that achieved a complete Metabolic Response (CR) or Partial Metabolic Response (PR) to therapy as assessed by the revised International Working Group Criteria. Complete Metabolic Response: Lymph nodes and extralymphatic sites: Score 1, 2, or 3 with or without a residual mass on 5-point (Daeuville) scale Bone Marrow: No evidence of FDG-avi disease No new lesions Partial Metabolic Response: \>Lymph nodes and extralymphatic sites: Score 4, 5 with reduced uptake compared with baseline and residual mass(es) of any size. Deauville Criteria for PET scan Interpretation in Lymphoma Five-point scale: 1. No Uptake 2. Uptake ≤ mediastinum 3. Uptake \>mediastinum but ≤ liver 4. Uptake moderately increased compared to liver at any site 5. Uptake markedly increased compared to the liver at any site or/and new sites of disease
Time frame: 4-6 months
Number of Patients With Grade III and IV Adverse Events
The number of patients that experienced grade III and grade IV adverse events that were deemed to be possibly, probably, or definitely related to study treatment. Adverse events were assessed using Common Toxicology Criteria for Adverse Events (CTCAE v4.0) criteria.
Time frame: 4-6 months
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