A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia
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ClinicalTrials.gov Identifier: NCT00233909 |
Recruitment Status
:
Completed
First Posted
: October 6, 2005
Last Update Posted
: April 1, 2008
|
Sponsor:
Kanisa Pharmaceuticals
Information provided by:
Kanisa Pharmaceuticals
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Brief Summary:
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leukemia, Myeloid | Drug: Zosuquidar Drug: gemtuzumab ozogamicin | Phase 1 Phase 2 |
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)
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 55 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label, Phase I/II Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia |
Study Start Date : | October 2005 |
Actual Primary Completion Date : | March 2008 |
Actual Study Completion Date : | March 2008 |
Resource links provided by the National Library of Medicine

Genetics Home Reference related topics:
Core binding factor acute myeloid leukemia
Cytogenetically normal acute myeloid leukemia
Familial acute myeloid leukemia with mutated CEBPA
Drug Information available for:
Gemtuzumab ozogamicin
Genetic and Rare Diseases Information Center resources:
Myeloid Leukemia
Acute Myeloid Leukemia
Acute Non Lymphoblastic Leukemia
U.S. FDA Resources
Information from the National Library of Medicine

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
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
No Contacts or Locations Provided
ClinicalTrials.gov Identifier: | NCT00233909 History of Changes |
Other Study ID Numbers: |
KAN-979-02 |
First Posted: | October 6, 2005 Key Record Dates |
Last Update Posted: | April 1, 2008 |
Last Verified: | March 2008 |
Keywords provided by Kanisa Pharmaceuticals:
Leukemia, Myeloid Relapse Chemotherapy Zosuquidar gemtuzumab ozogamicin (GO) |
Additional relevant MeSH terms:
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type |
Neoplasms Gemtuzumab Antineoplastic Agents |