Phase II Study of Two Distinct Tailored Temozolomide Regimens for Patients With Acute Myeloid Leukemia Age >= 60 Years and Poor Risk/Refractory Disease
This is a single institution phase II clinical trial (no control arm) to evaluate the
efficacy, safety and tolerability of tailored temozolomide therapy for patients with acute
myeloid leukemia (AML) and poor risk features.
Patients will have methylation status of AGAT promoter region determined by PCR. Patients
will be assigned to one of the two treatment groups depending on methylation status.
Temozolomide will be given orally for 7 or 21 days, accordingly (induction phase).
Patients achieving a complete remission after one or two cycles of chemotherapy will be
eligible to receive up to an additional 5 cycles of temozolomide for 5 or 19 days, depending
on the methylation status of the AGAT promoter (consolidation phase).
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the clinical efficacy of 2 different treatment regimens of temozolomide in patients with AML and poor prognostic features
Bruno Carneiro de Medeiros
United States: Institutional Review Board
|Stanford University School of Medicine||Stanford, California 94305-5317|