Lymphoma (Adult)
Randomized Phase II Study of Dose-Adjusted EPOCH-Rituximab-Bortezomib Induction Followed by Bortezomib Maintenance Versus Observation in Untreated Mantle Cell Lymphoma With Microarray Profiling and Proteomics
NCI-05-C-0170
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Investigator(s): |
Wyndham H. Wilson, M.D., Ph.D. Principal Investigator Phone: 301-435-2415 wilsonw@mail.nih.gov
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Therese White, R.N., M.S.N. Research Nurse Phone: 301-402-5886 whiteth@mail.nih.gov
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Peggy Shovlin, R.N., B.S.N. Research Nurse Phone: 301-594-6597 mshovlin@mail.nih.gov
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Primary Eligibility:
- 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
Treatment Plan:
Single-agent bortezomib
- Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8 and 11
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 over 3-5 seconds 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:- Beginning 8-12 weeks after the completion of dose-adjusted induction therapy, patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11
- Treatment repeats every 8 weeks for up to 18 months in the absence of disease progression or unacceptable toxicity
Arm II:- Patients undergo observation only
- Patients with disease progression receive bortezomib as in Arm I
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: 6/18/08
Updated: 9/7/06