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A Trial of Gemtuzumab Ozogami...

A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia

Last Updated: 2008-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-03-31

Brief Summary

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Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help Gemtuzumab Ozogamicin (GO) kill more cancer cells by making cancer cells more sensitive to the drug. It is not known whether Gemtuzumab Ozogamicin (GO) is more effective with or without zosuquidar in treating acute myeloid leukemia.

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Detailed Description

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Purpose:

Phase I: Determine the optimal dose and schedule of GO and zosuquidar when used in combination.

Phase II: Determine the complete remission rate (CR+CRp)

Conditions

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Leukemia, Myeloid

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Zosuquidar

Intervention Type DRUG

gemtuzumab ozogamicin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Morphologic evidence of acute myeloid leukemia in first relapse.
2. Phase I: 18 years or older, Phase II: 50 years or older

Exclusion Criteria

1. Prior treatment with zosuquidar
2. Any investigational agent within 1 month of enrollment and lack of recovery from toxicities secondary to those agents
3. History of stem cell transplant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers