NCT00313053

Study of mAb 216 With Chemotherapy for Treatment of Pediatric Relapsed or Refractory B-progenitor Acute Lymphoblastic Leukemia

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Clare Twist · Academic / Other
• Sex: All
• Age: 12 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I trial in patients with relapsed or refractory leukemia of a human monoclonal antibody that kills B cell acute lymphoblastic leukemia. The trial will study the safety, pharmacokinetics, and anti-tumor activity of the antibody given as a single agent and with vincristine.

Conditions

• Leukemia, Lymphocytic, Acute
• Leukemia
• Acute Lymphoid Leukemia (ALL)

Interventions

Type	Name	Description
DRUG	Human mAb 216	Two treatment courses of mAb infusion will be given, with the same dose of antibody administered on Day 0 and on Day 7.
DRUG	Vincristine	Vincristine 1.5 mg/m2/dose (max dose = 2 mg) IVP on weekly x 4 doses (Days 7, 14, 21, 28)

Timeline

• Start date: 2004-09-01
• Primary completion: 2008-04-01
• Completion: 2008-07-01
• First posted: 2006-04-11
• Last updated: 2016-06-03

Locations

1 site across 1 country: United States