A Randomized Phase II Trial of EPOCH Given Either Concurrently or Sequentially With Rituximab in Patients With Intermediate- or High-Grade HIV-Associated B-cell Non-Hodgkin's Lymphoma
I. To determine the complete response rate after treatment with EPOCH given either
concurrently or sequentially with rituximab.
I. To evaluate the toxicity of EPOCH given either concurrently or sequentially with
II. To evaluate the effect of EPOCH given either concurrently or sequentially with rituximab
on immune function (CD4, CD8 lymphocyte count) after two cycles of EPOCH, and 1 month, 3
months, 6 months, and 12 months after the completion of EPOCH.
III. To evaluate the effect of EPOCH given either concurrently or sequentially with
rituximab on HIV and EBV viral load after two cycles of EPOCH, and 1 month, 3 months, 6
months, and 12 months after the completion of EPOCH.
IV. To evaluate the relationship between EBV viral load and EBV CD8 cytotoxic T cells in the
peripheral blood and the presence of EBV in lymphoma tumor cells.
V. To determine whether rituximab or the concurrent use of antiretroviral therapy
significantly alters the steady state concentration of etoposide, doxorubicin, or
vincristine during the first cycle of therapy.
VI. To determine whether steady state concentration of etoposide or doxorubicin correlate
with nadir neutrophil and platelet count during the first cycle of therapy.
VII. To determine time to progression and overall survival in patients treated with EPOCH
given either concurrently or sequentially with rituximab.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to CD4 count (less than 100/mm^3 vs at least 100/mm^3), age-adjusted International
Prognostic Index adverse risk factors (0 or 1 vs 2 or 3), and concurrent antiretroviral
therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive rituximab intravenously (IV) over 2-4 hours prior to each course of
chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a
complete response after 4 courses of chemotherapy and rituximab receive additional rituximab
alone weekly for 2 weeks.
ARM II: Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks
after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment
Complete response defined by the International Response Criteria for Non-Hodgkin's Lymphoma
AIDS Associated Malignancies Clinical Trials Consortium
United States: Food and Drug Administration
|AIDS - Associated Malignancies Clinical Trials Consortium||Rockville, Maryland 20850|