Phase II Study of Flavopiridol (NSC 649890, IND 46, 211) in Timed Sequential Combination With Cytosine Arabinoside (Ara-C) and Mitoxantrone for Adults With Newly Diagnosed, Previously Untreated, Poor- Risk Acute Myelogenous Leukemia
OBJECTIVES:
Primary
- Determine the efficacy of flavopiridol, cytarabine, and mitoxantrone hydrochloride, in
terms of complete response, in patients with newly diagnosed, poor-risk acute myeloid
leukemia.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive flavopiridol 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.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Response
Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/L and a platelet count of 100,000 L, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A CR must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the CR.
6 months
No
Judith E. Karp, MD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
NCI-2012-02986
NCT00407966
October 2006
August 2009
Name | Location |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |