NCT00313079

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

A Phase I Study of mAb 216 With Chemotherapy for the Treatment of Adult Patients With Relapsed or Refractory B-Lineage Acute Lymphoblastic Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Steven E. Coutre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Lymphocytic
• Leukemia
• Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	MAb 216	Dosage: 1.25mg/kg intravenous with dose escalation
DRUG	Vincristine	Dosage: 1.5mg/m2 intravenous weekly X 4

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-02-01
• Completion: 2009-07-01
• First posted: 2006-04-11
• Last updated: 2012-07-03

Locations

1 site across 1 country: United States