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).
Interventional
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
2 months
Yes
Bruno Carneiro de Medeiros
Principal Investigator
Stanford University
United States: Institutional Review Board
HEMAML0004
NCT00611247
December 2007
January 2010
Name | Location |
---|---|
Stanford University School of Medicine | Stanford, California 94305-5317 |