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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Myeloid

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Trial Information

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


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)


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

KAN-979-02

NCT ID:

NCT00233909

Start Date:

October 2005

Completion Date:

March 2008

Related Keywords:

  • Leukemia, Myeloid
  • Leukemia, Myeloid
  • Relapse
  • Chemotherapy
  • Zosuquidar
  • gemtuzumab ozogamicin (GO)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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