Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Adults and Children With Previously Untreated Patients With Aggressive Non-Hodgkin's Lymphoma
The treatment of the intermediate and aggressive non-Hodgkin's lymphomas in adults and
children commonly induces complete responses in a sizable fraction of the treated
population, and about 2/3 of the complete responders appear to have prolonged disease-free
The present study assesses the activity and tolerability in previously untreated patients of
a regimen of EPOCH infusional chemotherapy given intensively with G-CSF support.
Assess complete response (CR) and progression-free survival (PFS) of dose-adjusted
EPOCH-Rituximab (DA-EPOCH-R) with G-CSF in agressive B-cell lymphomas.
Assess PFS in bcl-2 + lymphomas treated with dose-adjusted EPOCH-R, and determine if it is
significantly better than dose-adjusted EPOCH alone.
Obtain pilot information on the CR and PFS of dose-adjusted EPOCH with G-CSF in CD20
negative B cell lymphomas, anaplastic large cell lymphomas (ALCL) and peripheral T-cell
Assess toxicity of dose-adjusted EPOCH-Rituximab with G-CSF in agressive lymphomas.
Characterize the patterns of mdr-1, bcl-2, MIB-1 and mutant p53 expression in previously
untreated lymphoma patients.
Assess the effect of EPOCH-R on ovarian function and reserve in female patients with PMBL.
Non-Hodgkin's lymphomas in the following categories: diffuse large B-cell to include
gray zone lymphoma and follicular center cell grade IIIB, anaplastic large cell, aggressive
T-cell lymphomas and Burkitt Lymphoma.
Patients greater than or equal to 12 years old.
Stages II, III, IV for all subtypes, and Stage I for bulky (> 5 cm) primary mediastinal
lymphomas or Burkitt Lymphoma.
No prior systemic chemotherapy.
This study will estimate the complete response rate of a group of previously untreated
patients and the extent to which EPOCH infusional drug delivery accompanied by a
hematopoietic growth factor can increase the dose intensity of treatment.
Patients receive prednisone orally for 5 days, a 96 hour infusion of vincristine,
doxorubicin, and etoposide, and a bolus of cyclophosphamide on day 5.
Cycles are repeated every 21 days for a total of 6-8 cycles.
Patients with CD20 expressing tumors (i.e. mature B-cell lymphomas) will also receive
rituximab, the humanized monoclonal antibody against the CD20 receptor on day 1 of each
A total of 318 patients will be enrolled on this protocol at 5 different participating
Masking: Open Label, Primary Purpose: Treatment
Complete response after completion of study treatment
Wyndham H Wilson, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike
|Bethesda, Maryland 20892