Participants with acute myelogenous leukemia (AML) will be randomized to SCH 727965 or gemtuzumab ozogamicin. All participants with acute lymphoblastic leukemia (ALL) will receive SCH 727965. Part 1 of the study will determine the activity of SCH 727965 treatment in participants with AML and participants with ALL. Part 2 of the study will determine the activity of SCH 727965 treatment in participants with AML who experienced disease progression after standard treatment with gemtuzumab ozogamicin during Part 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.
Gemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15.
Overall response rate of initial treatment with SCH 727965 in subjects with AML or ALL.
Time frame: Time to identified response or disease progression on SCH 727965 in Part 1 (approx. 5 months).
Overall response rate in participants with AML treated with SCH 727965 after disease progression on comparator.
Time frame: Time to identified response or disease progression on SCH 727965 in Part 2 (approx. 5 months).
Time to disease progression for initial treatment with SCH 727965 in subjects with AML or ALL.
Time frame: Time to identified disease progression on SCH 727965 in Part 1 (approx. 5 months).
Overall response rate and time to progression of treatment with gemtuzumab ozogamicin in subjects with AML.
Time frame: Time to identified response or disease progression on gemtuzumab ozogamicin (approx. 5 months).
Time to disease progression for treatment with gemtuzumab ozogamicin in participants with AML.
Time frame: Time to identified disease progression on gemtuzumab ozogamicin (approx. 5 months).
Time to disease progression in participants with AML treated with SCH 727965 after disease progression on gemtuzumab ozogamicin
Time frame: Time to identified disease progression on SCH 727965 in Part 2 (approx. 5 months).
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