A phase I trial in patients with relapsed or refractory leukemia of a human monoclonal antibody that kills B cell acute lymphoblastic leukemia. Trial will study safety, pharmacokinetics, and anti tumor activity of the antibody given as a single agent and with vincristine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Dosage: 1.25mg/kg intravenous with dose escalation
Dosage: 1.5mg/m2 intravenous weekly X 4
Stanford University School of Medicine
Stanford, California, United States
In this phase I study the endpoint is the determination of the maximum tolerable dose without toxicity.
A decrease in leukemic blasts. The study will be terminated if unacceptable doseSecondary endpoints are a decrease in leukemic blasts. The study will be terminated if unacceptable dose limiting toxicity is found. This is a phase I trial to study safety.
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