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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:
Information provided by:
Kanisa Pharmaceuticals

Study Description
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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

Detailed Description:

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 Design
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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

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
 Neoplasms
Gemtuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents