Phase II Study of Dose-Adjusted EPOCH+/-Rituximab in Adults With Untreated Burkitt Lymphoma, c-MYC Positive Diffuse Large B-Cell Lymphoma and Plasmablastic Lymphoma

Inclusion Criteria

- INCLUSION CRITERIA:

- Burkitt lymphoma or B-cell lymphoma, unclassifiable, with features intermediate
between Diffuse Large B-cell lymphoma** and Burkitt Lymphoma, c-MYC + DLBCL or c-MYC+
plasmablastic lymphoma by histology. For c-MYC + cases, a MYC rearrangement must be
documented before study enrollment. If questions arise related to diagnosis, please
contact the NCI PI, Dr. Dunleavy or the NCI study coordinator, A. Nicole Lucas

- Age greater than or equal to 18 years. Because no dosing or adverse event data are
currently available on the use of EPOCH-R in patients < 18 years of age, children are
excluded from this study, but may be eligible for future pediatric trials

- Pathology confirmed by treating institution's Pathology Department.

- No prior treatment except patients may be entered if they have had prior
limited-field radiotherapy, a short course of glucocorticoids and/or cyclophosphamide
for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena
cava syndrome).

- All disease stages.

- HIV negative or positive.

- HIV positive patients on antiretrovival therapy regimen must be willing to suspend
all Highly Active Antiretroviral Therapy (HAART) except in circumstances described in
section 6.5.

- ECOG 0-4

- Ability of patient or durable power of attorney (DPA) for healthcare to give informed
consent.

- In the interest of completing the CALGB 50303 study, Alliance members should
consider enrolling patients with a diagnosis of DLBCL onto the CALGB 50303
study.

EXCLUSION CRITERIA:

- Inadequate renal function, defined as serum Cr > 1.5 or creatinine clearance <
50ml/min/1.73m2 unless lymphoma related.

- Inadequate hepatic or hematological function: bilirubin greater than 2 mg/dl (total)
except greater than 5 mg/dl in patients with Gilbert's syndrome as defined by greater
than 80% unconjugated; ANC less than 1000 and platelets less than 75,000 unless
lymphoma related.

- The effects of EPOCH-R on the developing human fetus are unknown. For this reason and
because chemotherapy agents are known to be teratogenic, female subject of
child-bearing potential not willing to use an acceptable method of birth
control(i.e., a hormonal contraceptive, intra-uterine device, diaphragm with
spermicide, condom with spermicide, or abstinence) for the duration of the study and
one year beyond treatment completion will not be eligible to participate in the
study.

- Female subject pregnant or breast-feeding. Confirmation that the subject is not
pregnant must be established by a negative serum beta-human chorionic gonadotropin
(beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not
required for women without child-bearing potential.

- The effects of EPOCH-R on the developing human fetus are unknown. For this reason and
because chemotherapy agents are known to be teratogenic, male subject unwilling to
use an acceptable method for contraception for the duration of the study and one year
beyond treatment completion, will not be eligible to participate in the study.

- History of a prior invasive malignancy in past 5 years.

- Active symptomatic ischemic heart disease, myocardial infarction or congestive heart
failure within the past year. If echo is obtained the LVEF should exceed 40%.

- Serious concomitant medical illnesses that would jeopardize the patient's ability to
receive the regimen with reasonable safety.

- HIV positive patients with advanced immune supression and evidence of HIV resistant
to all combinations of antiretroviral therapy considered at high risk of non lymphoma
related death within 12-months due to other AIDS complications should not be enrolled
on the study.