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Investigator(s):
Kieron Dunleavy, M.D. Principal Investigator Phone: 301-435-1007 dunleavk@mail.nih.gov	Wyndham H. Wilson, M.D., Ph.D. Protocol Chair Phone: 301-435-2415 wilsonw@mail.nih.gov
Referral Contact(s):
Peggy Shovlin, R.N., B.S.N. Research Nurse Phone: 301-594-6597 mshovlin@mail.nih.gov

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Key Eligibility Criteria:

• Histologically confirmed classical or atypical Burkitt lymphoma or c-MYC + DLBCL; pathology confirmed by treating institution’s Pathology Department
• ≥ 18 years of age
• ECOG 0–4
• HIV negative or positive
• HIV-positive patients must be willing to suspend HAART therapy for the duration of study
• No prior treatment except local radiation or short-term steroids for acute symptoms
• Must have normal organ function
• Not pregnant or nursing; fertile patients must use effective contraception for the duration of the study and for 1 year after completion of study treatment
• No other prior malignancy within 5 years
• No medical condition that would preclude study participation

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Study Outline:

Patients are randomized based on risk level (low risk vs. high risk) to one of two treatment arms.

Low-risk patients:

• Patients receive three cycles of DA-EPOCH-RR (two doses of rituximab per cycle)
• FDG-PET will be performed after Cycle 2 completion; if the FDG-PET is positive, the patient will complete treatment as outlined for high-risk patients (i.e., receive four additional cycles of DA-EPOCH-R), with a repeat FDG-PET after completion of Cycle 6

High-risk patients:

• Patients will receive six cycles of DA-EPOCH-R (one dose of rituximab per cycle)
• FDG-PET will be performed after Cycle 2 completion; if the FDG-PET is positive, it will be repeated after completion of Cycle 6

CSF cytology and flow cytometry for analysis of Burkitt lymphoma:

• High-risk CSF-negative patients will receive prophylactic CNS treatment with intrathecal methotrexate
• CSF-positive patients will receive intrathecal treatment

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/6/12
Updated: 12/19/11