Timed Sequential Therapy (TST) With Alvocidib (Flavopiridol), Ara-C and Mitoxantrone (FLAM) Versus "7+3" for Newly Diagnosed Acute Myelogenous Leukemia (AML)
The purpose of this research study is to compare two different chemotherapy regimens to try
to find out which way might be safer and/or more effective against Acute Myelogenous
Leukemia (AML). This is a Phase II study. Phase II studies are designed to examine whether
specific drugs or drug combinations have activity against a specific type of cancer. The
combination of flavopiridol with ara-C and mitoxantrone (FLAM) is an experimental
combination for treating newly diagnosed AML with high risk features. In this study the
flavopiridol, ara-C and mitoxantrone is being compared to traditional chemotherapy used to
treat newly diagnosed AML of ara-C and daunorubicin (7+3).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The rate of complete remission (CR) after 1 cycle of induction therapy
To compare the rate of complete remission (CR) after 1 cycle of induction therapy with the timed sequential combination of flavopiridol, cytosine arabinoside (ara-C), and mitoxantrone (FLAM) vs. traditional "7+3" (ara-C + Daunorubicin) for young adults (age 18 to 70) with newly diagnosed, previously untreated, intermediate risk or poor-risk acute myelogenous leukemia (AML)
1 cycle, approximately 6 weeks
No
Judith Karp, MD
Study Chair
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
United States: Food and Drug Administration
NCI 8972 (JHOC 1101)
NCT01413880
May 2011
Name | Location |
---|---|
SKCCC | Baltimore, Maryland 21287 |