Monoclonal Antibody (mAb) 216 With Chemotherapy in Adult Relapsed or Refractory B-Lineage Acute Lymphoblastic Leukemia
NCT00313079 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2012-07-03
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
- DRUG
-
MAb 216
Dosage: 1.25mg/kg intravenous with dose escalation
- DRUG
-
Vincristine
Dosage: 1.5mg/m2 intravenous weekly X 4
Sponsors & Collaborators
-
Steven E. Coutre
lead OTHER
Principal Investigators
-
Nelson N Teng · Stanford University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-05-31
- Primary Completion
- 2009-02-28
- Completion
- 2009-07-31
Countries
- United States
Study Locations
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