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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

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Key Eligibility Criteria:

• Age 18 and over
• Diagnosis of mantle cell lymphoma; all stages and variants allowed
• Untreated mantle cell lymphoma (prior short course of steroids and or local radiotherapy for control of symptoms allowed)
• Bilirubin < 2 mg/dL*
• Creatinine ≤ 1.5 mg/dL*
• Absolute neutrophil count > 1,000/mm³*
• Platelet count > 75,000/mm³*
  
  *Unless impairment due to organ involvement by lymphoma



• No CNS lymphoma
• No active symptomatic ischemic heart disease
• No other invasive malignancy within the past 5 years

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Study Outline:

Single-agent bortezomib

• Patients receive four doses of bortezomib IV over 3 weeks

Dose-adjusted induction therapy

• Beginning within 22-28 days after the start of single-agent bortezomib, patients receive rituximab IV on day 1 followed by etoposide, doxorubicin, and vincristine IV continuously over 96 hours on days 1-4
• Patients also receive bortezomib IV on days 1 and 4; oral prednisone twice daily on days 1-5; and cyclophosphamide IV over 15 minutes on day 5
• Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and continuing until day 15 or until blood counts recover
• Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity

Maintenance therapy

• Patients who achieve at least a partial response to dose-adjusted induction therapy are randomized to 1 of 2 arms.

Arm I:

• Patients receive bortezomib IV for up to 18 months in the absence of disease progression or unacceptable toxicity

Arm II:

• Patients undergo observation only
• Patients with disease progression:
• Patients receive bortezomib IV for up to 18 months in the absence of disease progression or unacceptable toxicity

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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: 1/23/13