A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia
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.
Drug: gemtuzumab ozogamicin
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
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)