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

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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Key information

Conditions

Leukemia, Myeloid Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Zosuquidar

Drug

Gemtuzumab Ozogamicin

Drug

Sponsors and collaborators

Lead sponsor

Kanisa Pharmaceuticals

Industry

Registry information

Official study title

An Open-Label, Phase I/II Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Oct 6, 2005
Registry last updated: Apr 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed