MedTrace Logo

Phase I Using Velcade & Idarubicin in Elderly and Relapsed AML

NCT00382954 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2010-09-29

No results posted yet for this study

Summary

The purpose of this study is to determine the maximal tolerated dose (MTD) of bortezomib and idarubicin given in combination to newly diagnosed AML patients \>60 years or relapsed AML patients.

Another purpose of this study is to determine the dose limiting toxicities associated with bortezomib in combination with idarubicin in newly diagnosed AML patients \>60 years or relapsed AML patients.

Conditions

  • Acute Myelogenous Leukemia

Interventions

DRUG

Velcade

velcade (4 original dosing levels with 3 modified dosing levels) I.V. on days 1, 4, 8, 11, 15, 18, 22, and 25 for 4 weeks concurrent with the Idarubicin

DRUG

Idarubicin

I.V., 8, or 10 or 12 mg/m\^2 weekly (days 1, 8, 15, and 22) for 4 weeks

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Kentucky

    lead OTHER

Principal Investigators

  • Dianna Howard, MD · University of Kentucky

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00382954 on ClinicalTrials.gov