drugset / Trial / NCT00313079

Monoclonal Antibody (mAb) 216 With Chemotherapy in Adult Relapsed or Refractory B-Lineage Acute Lymphoblastic Leukemia

NCT00313079

Phase 1 Completed 9 enrolled Steven E. Coutre
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2006-05
Primary completion
2009-02
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Subject MAb 216 Monoclonal antibody 1.25 mg/kg Intravenous
Subject Vincristine Small molecule 1.5 mg/m2