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

Primary Purpose

Leukemia, Myeloid

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Zosuquidar
gemtuzumab ozogamicin
Sponsored by
Kanisa Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid focused on measuring Leukemia, Myeloid, Relapse, Chemotherapy, Zosuquidar, gemtuzumab ozogamicin (GO)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 4, 2005
    Last Updated
    March 28, 2008
    Sponsor
    Kanisa Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00233909
    Brief Title
    A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2005 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    March 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Kanisa Pharmaceuticals

    4. Oversight

    5. Study Description

    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.
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leukemia, Myeloid
    Keywords
    Leukemia, Myeloid, Relapse, Chemotherapy, Zosuquidar, gemtuzumab ozogamicin (GO)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    55 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Zosuquidar
    Intervention Type
    Drug
    Intervention Name(s)
    gemtuzumab ozogamicin

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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