Leukemia, Myeloid Clinical Trial
Official title:
Phase II Study of Two Distinct Tailored Temozolomide Regimens for Patients With Acute Myeloid Leukemia Age > 60 Years and Poor Risk/Refractory Disease
Open-label, non-randomized, parallel assignment, phase 2 trial assessing the safety and efficacy of distinct temozolomide treatment regimens for patients with AML and poor prognosis
This is a single institution phase 2 clinical trial evaluating the efficacy, safety, and
tolerability of tailored temozolomide therapy for patients with acute myeloid leukemia (AML)
and poor risk features.
Patients will be assigned to 1 of 2 parallel treatment groups based on their AGAT promoter
region methylation status, as determined by PCR.
Patients achieving a complete remission after 1 to 2 cycles of chemotherapy will be eligible
to receive up to an additional 5 cycles of temozolomide of 5 or 19 days, depending on the
methylation status of the AGAT promoter (consolidation phase).
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