Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase I Study of Azacitidine Combined With Mitoxantrone and Etoposide (A-NOVE) Chemotherapy for Patients' Age ≥ 60 With Poor Prognosis Acute Myeloid Leukemia (AML)
This phase I trial studies the best dose of azacitidine and to see how well it works with mitoxantrone hydrochloride and etoposide in treating older patients with acute myeloid leukemia that has a lower chance of responding to treatment or higher risk of returning (poor prognosis). Drugs used in chemotherapy, such as azacitidine, mitoxantrone hydrochloride, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To determine the highest tolerated dose of two dosing schedules of azacitidine when
combined with mitoxantrone (mitoxantrone hydrochloride) and etoposide (A-NOVE) chemotherapy
in poor prognosis older patients with acute myeloid leukemia (AML).
II. To evaluate the toxicity of this regimen.
SECONDARY OBJECTIVES:
I. To determine the complete response (CR) rate and using this regimen. II. To evaluate
changes in topoisomerase II activity, deoxyribonucleic acid (DNA) methylation and DNA
expression arrays in leukemia cells during azacitidine treatment, and to correlate these
changes with responses to A-NOVE chemotherapy.
III. To evaluate relapse-free survival (RFS) and overall survival (OS) in patients receiving
post-remission consolidation with A-NOVE in patients achieving CR. (OS follow-up
discontinued as of 08/07/2014)
OUTLINE: This is a dose-escalation study of azacitidine.
Patients receive induction therapy comprising azacitidine subcutaneously (SC) once daily
(QD) on days 1-7, mitoxantrone hydrochloride IV over 30 minutes, and etoposide IV over 1
hour on days 4-8. Patients may receive up to 2 additional courses of the same treatment as
re-induction or consolidation therapy beginning 35-60 days from the start of the previous
course.
After completion of study treatment, patients are followed up every 3 months.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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