Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Phase 1b/2 Study of Dinaciclib (SCH 727965) and Ofatumumab in Relapsed and Refractory CLL/SLL/B-PLL
This phase I/II trial studies the side effects and the best dose of ofatumumab and dinaciclib and to see how well they work in treating patients with relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, or B-cell prolymphocytic leukemia. Monoclonal antibodies, such as ofatumumab, can find cancer cells and help kill them. Dinaciclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ofatumumab together with dinaciclib may kill more cancer cells.
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.
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