Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Clinical Trial
Official title:
Phase II Study of Alvocidib (NSC 649890, Flavopiridol) in Timed Sequential Combination With Cytosine Arabinoside (Ara-C) and Mitoxantrone for Adults With Newly Diagnosed, Previously Untreated, Poor-Risk Acute Myelogenous Leukemias
This phase II trial is studying the side effects and how well giving alvocidib together with cytarabine and mitoxantrone works in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as alvocidib, cytarabine, and mitoxantrone, 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 efficacy and toxicities of flavopiridol (alvocidib) followed by ara-C
and mitoxantrone in adults with newly diagnosed acute myelogenous leukemia (AML) with
poor-risk features.
II. To determine the disease free and overall survival of patients exhibiting a response to
treatment with flavopiridol followed by ara-C and mitoxantrone.
OUTLINE:
Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72
hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Beginning
35-63 days after completion of course 1, patients achieving complete or partial remission
may receive a second course of treatment as above.
Patients age 50 and over with "core binding factor" acute myeloid leukemia (AML) (e.g.,
t[8;21], inv[16], or t[16;16]) achieving a complete remission after course 1 of treatment
may receive 3-4 courses of consolidation therapy comprising high-dose cytarabine at the
discretion of the investigator.
After completion of study treatment, patients are followed periodically.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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