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Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

NCT00660036 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2016-01-15

No results posted yet for this study

Summary

The purpose of this study is to investigate the combination of gemtuzumab ozogamicin, mitoxantrone and etoposide as second line therapy in patients with acute myeloid leukemia.

Conditions

Interventions

DRUG

Gemtuzumab ozogamicin

On Day 6 of an inpatient hospital stay: Based on the study design patients will be treated with one of three doses (3 mg/m\^2, 6 mg/m\^2 or 9 mg/m\^2), administered intravenously in 100 ml of 0.9% sodium chloride over 2 hours.

DRUG

Mitoxantrone

On Days 1-3 of an inpatient hospital stay: 10 mg/m\^2 administered via IVPB (intravenous piggy-back) in 50ml normal saline (NS) over 15 minutes

DRUG

Etoposide

On Days 1-5 of an inpatient hospital stay: 100 mg/m\^2 administered intravenously in 500 ml of 0.9% sodium chloride over 2 hours

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Michael Boyiadzis, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-04-30
Completion
2011-04-30

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 NCT00660036 on ClinicalTrials.gov