Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase I/II Study of Dasatinib and Rituximab for Relapsed/Refractory Chronic Lymphocytic Leukemia
This is an open-label phase I/II study that will investigate the combination of dasatinib and
rituximab therapy in patients with relapsed/refractory CLL. In phase I, eligible subjects
will take either 100 mg or 140 mg of dasatinib daily along with rituximab on day 1 of each
cycle for 6 cycles. In phase II, eligible subjects will all receive the same dose of
dasatinib, as established in the phase I portion, along with rituximab on day 1 of each cycle
for 6 cycles.
The investigators hypothesize that the combination of dasatinib and rituximab will
demonstrate efficacy in the treatment of patients with relapsed/refractory CLL.
In phase I, patients will be enrolled in a standard "3+3" dose escalation scheme with two
dasatinib cohort doses of 100 mg QD and 140 mg QD x 28 days/cycle with rituximab 500 mg/m2 on
day 1 of each cycle (375 mg/m2 on day 1 of cycle 1 only). During the first cycle of each dose
cohort patients will receive dasatinib on days -7 to 0 to allow for pharmacokinetic and
pharmacodynamic analysis of single agent dasatinib dosing. Cohorts will be assessed for DLTs
during the first 2 cycles. Treatment will continue for 6 cycles or until intolerable toxicity
or disease progression. It is estimated that accrual of 3-6 patients will be completed in 4-6
months depending on DLTs observed.
The dasatinib dose established in phase I will move forward to the phase II setting. If there
are no DLTs, the phase II dose will be chosen based on PD parameters. Dasatinib will be
administered for 28 days/cycle with rituximab 500 mg/m2 on day 1 of each cycle (375 mg/m2 on
day 1 of cycle 1 only) for 6 cycles or until intolerable toxicity or disease progression. For
this portion of the study, up to an additional 22 patients will be enrolled over a 6-month
period for a total of 28 patients at the chosen dose level.
For both, phase I and II, patients will complete up to six cycles of D+R therapy and
endpoints will be evaluated 8 weeks after treatment. Patients will be followed until disease
progression, study withdrawal or death. Patients with a PR or CR will be eligible to remain
on dasatinib alone.
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