Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
Phase I Investigation of the Feasibility of Combining 5-azacytidine With Highdose Cytarabine (HiDAC) and Mitoxantrone Chemotherapy in a Sequential Manner for Remission Induction in High-risk Acute Myelogenous Leukemia (AML)
This phase I trial studies the side effects and best dose of azacitidine when given together with cytarabine and mitoxantrone hydrochloride in treating patients with high-risk acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, cytarabine, and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also help cytarabine and mitoxantrone hydrochloride work better by making the cancer cells more sensitive to the drugs
PRIMARY OBJECTIVES:
I. To establish the recommended phase II dose of 5-azacytidine (azacitidine) when combined
with high-dose cytarabine (HiDAC) and mitoxantrone (mitoxantrone hydrochloride) chemotherapy
in high-risk acute myeloid leukemia (AML) patients.
SECONDARY OBJECTIVES:
I. To determine the complete remission (CR) rate following the use of induction chemotherapy
regimen of 5-azacytidine followed by high-dose cytarabine (HiDAC) and mitoxantrone
chemotherapy in high-risk AML patients.
II. To determine the toxicity of the combination regimen. III. To determine the disease-free
survival (DFS) and overall survival (OS) of the patient population.
IV. To determine the gene expression levels of topoisomerase II and deoxycytidine kinase in
leukemia blasts pre-treatment and following therapy with 5-azacytidine.
V. To collect specimens for banking for use in future research studies with a view to
elucidating the predictors of response to epigenetic therapies.
OUTLINE: This is a dose-escalation study of azacitidine.
INDUCTION: Patients receive azacitidine intravenously (IV) over 10-40 minutes or
subcutaneously (SC) once daily (QD) on days 1-5, cytarabine IV over 4 hours on days 6 and 10,
and mitoxantrone hydrochloride IV over 60 minutes on days 6 and 10.
CONSOLIDATION: Patients receive azacitidine IV over 10-40 minutes or SC QD on days 1-5.
Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or
unacceptable toxicity. Patients ineligible for allogeneic stem cell transplantation continue
on to maintenance.
MAINTENANCE: Patients receive azacitidine IV over 10-40 minutes or SC QD on days 1-5. Courses
repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years.
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