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
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
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
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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