A Phase II Study of Rituximab + ABVD for Patients With Hodgkin's Disease
Before treatment starts, patients will have a physical exam. Bone marrow samples will be
taken. Blood samples (4 to 8 tablespoons) will be taken before and during the study. A
chest x-ray, CT scans of the abdomen and pelvis, and a gallium scan will be done if
Patients in this study will receive rituximab by vein over 3 to 8 hours weekly for 6 weeks
in a row. ABVD will be injected over 3 hours every other week for a total of 12 treatments.
On the cycles where both rituximab and ABVD are given, rituximab will be given on day 1,
and ABVD will be given on day 2. Response to therapy will be determined after 3 months and
at the end of therapy (6 months). At the end, patients may receive radiation therapy to
areas of large masses. All treatments can be given in an outpatient setting.
Scans and x-rays will be repeated if needed after completion of therapy and every 3 months
from then on. If tumors do not shrink after 3 months of therapy, patients will be offered a
This is an investigational study. Although ABVD is considered the standard treatment for
patients with Hodgkin's disease, the combination of ABVD with rituximab is considered
investigational. All drugs involved in this study are commercially available and are
approved by the FDA. Up to 85 patients will take part in this study. All will be enrolled
at M. D. Anderson. This protocol is partially funded by a research grant from Genentech.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
5-year failure-free survival rate for patients with Hodgkin's disease given Rituximab with ABVD
Event free survival (EFS) using Rituximab+ABVD (RABVD) in newly diagnosed patients with advanced stage classical Hodgkin lymphoma (HL). Event-free Survival (EFS) analyzed every 6 months.
Baseline to 5 Years or until disease progression
Anas Younes, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD . Anderson Cancer Center||Houston, Texas 77030|