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

NCT00949988 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-08-14

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Dasatinib and Rituximab

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

Sponsors & Collaborators

Principal Investigators

  • Januario Castro, M.D. · Clinical Professor, Blood and Bone Marrow Transplant Division

  • Thomas J Kipps, M.D., Ph.D. · Professor of Medicine, Evelyn and Edwin Tasch Chair in Cancer Research in the UCSD School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00949988 on ClinicalTrials.gov