A Study of Dasatinib and Rituximab for Relapsed/Refractory Chronic Lymphocytic Leukemia

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT00949988
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dasatinib and Rituximab — DRUG
    In Phase I, subjects will be enrolled into a "3+3" dose escalation scheme with two dasatinib cohort doses of 70 mg QD and 100 mg QD to be given continuously during each 28-day cycle. All subjects will also receive rituximab 500 mg/m2 on day 1 of each cycle (375 mg/m2 on day 1 of cycle 1 only). There will be a pre-phase for each dose cohort when subjects will receive single-agent dasatinib from days -7 to -1 to allow for PK and PD assessment. Cohorts will be assessed for dose-limiting toxicities for two cycles before accrual of additional

Study Details

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.

Key Dates

Start date
May 31, 2009
Status verified
Jul 2019
Primary completion
Apr 30, 2012
Completion
Apr 30, 2012

Study Design

Enrollment
3 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dasatinib - 100 mg (Phase I)
    Dasatinib - 100 mg (Phase I)
  • Active Comparator: Dasatinib - 70 mg (Phase I)
    Dasatinib - 70 mg (Phase I)

Primary Outcome Measure

Phase I: To Determine the Dose-limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD) of D+R Therapy in Patients With Relapsed/Refractory CLL [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San Diego Moores Cancer CenterLa JollaCalifornia92093-

Find similar trials in La Jolla, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of California San Diego Moores Cancer Center· La Jolla, CA

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