Lymphoma Clinical Trial
Official title:
A Phase I-II Study of Pentostatin, Cyclophosphamide, Rituximab, and Mitoxantrone in Previously Treated Patients With Chronic Lymphocytic Leukemia and Other Low Grade B-Cell Neoplasms
RATIONALE: Pentostatin may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and
mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing
the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can
block cancer growth in different ways. Some block the ability of cancer cells to grow and
spread. Others find cancer cells and help kill them or carry cancer-killing substances to
them. Giving pentostatin together with combination chemotherapy and rituximab may kill more
cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of mitoxantrone
when given together with pentostatin, cyclophosphamide, and rituximab and to see how well it
works in treating patients with chronic lymphocytic leukemia or other low-grade B-cell
cancer.
OBJECTIVES:
- To determine the dose of mitoxantrone hydrochloride that can be safely administered
with pentostatin, cyclophosphamide, and rituximab in patients with previously treated
chronic lymphocytic leukemia or other low-grade B-cell malignancies.
- To characterize the toxicity of this regimen in these patients.
- To determine the response rate in patients treated with this regimen.
OUTLINE: This is a phase I, dose-escalation study of mitoxantrone hydrochloride followed by
a phase II study.
- Phase I: Patients receive pentostatin IV, cyclophosphamide IV, and mitoxantrone
hydrochloride IV on day 1. Patients also receive rituximab IV on day 1 beginning in
course 2. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
- Phase II: Patients receive pentostatin, cyclophosphamide, rituximab, and mitoxantrone
hydrochloride (at the maximum tolerated dose determined in phase I) as in phase I.
All patients receive either pegfilgrastim subcutaneously (SC) on days 1-4 following each
course or filgrastim or sargramostim SC beginning 2 days after each course until blood
counts recover.
Patients undergo blood collection and bone marrow biopsy periodically for assessment of
therapy response by biomarker and laboratory studies. Samples are analyzed for molecular
genetics for IgH arrangement by PCR and for response by immunoelectrophoresis. Some samples
are analyzed for response by flow cytometry or fluorescence in situ hybridization (FISH).
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 63 patients (18 patients for phase I and 45 patients for phase
II) will be accrued for this study.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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