Phase I/II Study of PR104 in Subjects With Refractory/Relapsed Acute Leukemia Using Adaptive Dose Selection
A single arm study defining the recommended dose of PR104 for each subpopulation in this
Following informed consent, subjects will undergo baseline evaluation with a history,
physical exams, blood work, and disease assessment. Subjects will be assigned a dose of
PR104 based on a Bayesian model maintained at the Statistical department at MD Anderson
Cancer Center. The model will be updated with both toxicity and efficacy data as it is
generated for each subject. New subjects will receive the currently predicted best dose for
their respective subset based on prior treatment, age and duration of prior response.
PR104 will be administered initially as induction therapy for up to 3 cycles. Response will
be assessed around day 42 (+/- 2 days) of the study. Subjects who obtain a CR or CRp will
receive consolidation therapy for up to 4 additional cycles.
Subjects will be evaluated each week during the induction phase of the study. During the
consolidation phase of the study, subjects will be evaluated on Day 1 of each cycle and as
clinically indicated. Subjects with clinically significant progression will be removed from
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the optimal individualized dose to give each refractory/relapsed AML subject based on his/her covariates (prior CR duration, prior number of salvage therapies, age).
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Seattle Cancer Care Alliance||Seattle, Washington 98109|