Trial Information

Phase II Trial of Rituximab -ABVD for Classical Hodgkin's Disease

OBJECTIVES:

Primary

- Investigate plasma DNA biomarkers, including plasma clonal immunoglobulin DNA, tumor
suppressor gene methylation, and Epstein-Barr virus DNA, in patients receiving
rituximab and doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD)
for newly diagnosed stage II-IV classical Hodgkin's lymphoma.

- Characterize the impact of rituximab on these markers.

- Characterize the relationship between marker detection and clinical outcome.

Secondary

- Estimate the event-free survival of patients with newly diagnosed Hodgkin's lymphoma
treated with rituximab and ABVD.

- Assess the presence of Hodgkin's lymphoma stem cells in peripheral blood mononuclear
cells at baseline, after treatment with rituximab, and after treatment with ABVD.

- Assess whether plasma DNA biomarkers add information to fludeoxyglucose F 18 positron
emission tomography (FDG-PET) in assessing tumor response.

OUTLINE: Patients receive doxorubicin hydrochloride IV, vinblastine IV, bleomycin IV, and
dacarbazine IV (ABVD) on days 1 and 15 of all courses. Patients also receive rituximab IV on
days -6, 1, 8, 15, and 22 of ABVD course 1 and on day 1 only of ABVD courses 2, 4, and 6.
Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or
unacceptable toxicity.

Patients with bulky disease may undergo radiotherapy.

Plasma samples are obtained during treatment for investigation of tumor markers (e.g.,
immunoglobulin rearrangement, patterns of DNA methylation, and the presence of Epstein-Barr
virus DNA). Patients undergo fludeoxyglucose F18 positron emission tomography periodically
during the study.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.