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Investigator(s):
Wyndham H. Wilson, M.D., Ph.D. Principal Investigator 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	Therese White, R.N., M.S.N. Research Nurse Phone: 301-402-5886 whiteth@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed de novo B-cell non-Hodgkin’s lymphoma (NHL) of 1 of the following WHO histologic subtypes:
  • Diffuse large cell lymphoma, including any of the following morphologic variants: Centroblastic, Immunoblastic, T-cell/histiocyte rich, Anaplastic
  • Mediastinal (thymic) large cell lymphoma
  • Intravascular large cell lymphoma
• Stage I primary mediastinal (thymic) OR stage II-IV disease
• CD20-positive disease
• No underlying low-grade lymphoma
• No known lymphomatous CNS involvement; lumbar puncture required unless there are no neurological symptoms
• No prior rituximab; no concurrent epoetin cytokines
• No prior chemotherapy for other malignancies; no prior cytotoxic chemotherapy; no other concurrent chemotherapy
• Prior short course (< 10 days) glucocorticoids allowed for an urgent local disease complication at diagnosis; no concurrent hormonal therapy except steroids for adrenal failure or hormones for non-disease-related conditions; no concurrent dexamethasone or other steroidal antiemetics
• Prior limited field radiotherapy allowed for an urgent local disease complication at diagnosis; no concurrent radiotherapy except for isolated CNS lesions
• No active bleeding unrelated to NHL
• No active ischemic heart disease; no congestive heart failure
• No active uncontrolled bacterial or viral infection unrelated to NHL; HIV negative

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Treatment Plan:

Patients are randomized to 1 of 2 treatment arms:

Arm I (R-CHOP)

• Patients receive rituximab IV, cyclophosphamide IV, doxorubicin IV over 3-5 minutes, and vincristine IV on day 1 and oral prednisone once daily on days 1-5
• Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity

Arm II (EPOCH-R)

• Patients receive rituximab IV on day 1; doxorubicin IV, etoposide IV, and vincristine IV continuously over 96 hours on days 1-4; cyclophosphamide IV on day 5; and oral prednisone twice daily on days 1-5
• Patients also receive filgrastim (G-CSF) once daily on days 6-17 or until blood counts recover
• Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for up to 3 years.

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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, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/19/08
Updated: 1/11/07