Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase I Study of Flavopiridol, Fludarabine and Rituximab in Indolent B-cell Lymphoproliferative Disorders and Mantle Cell Lymphoma
This phase I trial studies the side effects, best way to give, and the best dose of alvocidib when given together with fludarabine phosphate and rituximab in treating patients with previously untreated or relapsed lymphoproliferative disorders or mantle cell lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy such as alvocidib and fludarabine use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To determine a safe and tolerated dose of flavopiridol (alvocidib) in combination with
standard dose rituximab and fludarabine (fludarabine phosphate) in patients with indolent
B-cell lymphoproliferative disorders and mantle cell lymphoma.
II. To assess the toxicity of the combination regimen of flavopiridol, rituximab and
fludarabine in patients with indolent B-cell lymphoproliferative disorders and mantle cell
lymphoma.
III. To determine the safety, toxicity and efficacy of administering flavopiridol as a
30-minute bolus followed by 4-hour infusion, in combination with rituximab and fludarabine
in patients with indolent B-cell lymphoproliferative disorders and mantle cell lymphoma.
SECONDARY OBJECTIVES:
I. To determine pharmacokinetics of the combination regimen of flavopiridol, rituximab and
fludarabine in patients with indolent B-cell lymphoproliferative disorders and mantle cell
lymphoma.
II. To determine pharmacodynamics of the combination regimen of flavopiridol, rituximab and
fludarabine in patients with indolent B-cell lymphoproliferative disorders and mantle cell
lymphoma.
OUTLINE: This is a dose-escalation study of alvocidib.
Patients receive fludarabine phosphate intravenously (IV) over 15-30 minutes on days 1-5 and
rituximab IV over 3-4 hours on day 1. Alvocidib is administered IV over 60 minutes on day 1
in cohort 1; on days 1 and 2 in cohort 2; and on days 1, 2, and 3 in cohort 3. In cohorts 4
and 5, patients receive fludarabine phosphate and rituximab as above and alvocidib IV over
30 minutes and then IV over 4 hours on day 1 of courses 2-6. Treatment repeats every 28 days
for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
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