Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. To determine the tolerable dose of combination therapy with ofatumumab and dinaciclib (phase 1b component) in chronic lymphocytic leukemia (CLL), small lymphocytic leukemia (SLL), and B-cell prolymphocytic leukemia (B-PLL). II. To characterize the toxicity of combination therapy with ofatumumab and dinaciclib in CLL/SLL/B-PLL. III. To determine the overall response rate associated with this treatment as assessed by consensus response criteria. (Phase II) SECONDARY OBJECTIVES: I. To estimate progression-free survival (PFS) after combination treatment with ofatumumab and dinaciclib. II. To characterize the pharmacokinetics of dinaciclib when given in combination with ofatumumab. III. To correlate pharmacokinetic features of dinaciclib with response, toxicity (particularly tumor lysis syndrome), and pharmacodynamic endpoints. IV. To perform detailed baseline and serial pharmacodynamic studies of combination therapy with ofatumumab and dinaciclib and correlate these with response to therapy. V. To correlate baseline disease-risk parameters (i.e., zeta-chain-associated protein kinase \[ZAP\]-70 expression, interphase cytogenetics, immunoglobulin heavy chain variable region \[IgVH\] mutational analysis, and other clinical prognostic factors) with response to therapy. OUTLINE: This is a phase I, dose-escalation study followed by a phase II study. Patients receive ofatumumab intravenously (IV) over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib IV over 2 hours on days 2, 8, and 15 of course 2, and on days 1, 8, and 15 of courses 3-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for up to 3 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
