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

NCT00313053 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2016-06-03

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Clare Twist

    lead OTHER

Principal Investigators

  • Clare J. Twist M.D. · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2008-04-30
Completion
2008-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00313053 on ClinicalTrials.gov