Clinical Trial VICCHEM1151
Randomized Phase II Trial of Timed Sequential Therapy (TST) with Alvocidib (Flavopiridol), ara-C and mitoxantrone (FLAM) vs. "7+3" for Adults age 70 and Under with Newly Diagnosed Acute Myelogenous Leukemia (AML)
- Protocol No. VICCHEM1151
- Open Date: 08/17/2012
- Staging: Phase II
- Age Group: Adults
- Scope: National
- Objective: 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)
- Disease Sites: Leukemia
- Therapies: Chemotherapy - cytotoxic
- Drugs: Cytosine Arabinoside (araC); Daunorubicin (Daunomycin); Flavopiridol; Mitoxantrone
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01413880
- Secondary Protocol No: Not Specified
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 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). Ara-C, mitoxantrone and daunorubicin are given commonly to people with AML. The combination of flavopiridol with ara-C and mitoxantrone (designated FLAM) has been given to over 500 people with all types of acute leukemias, including 150 people with newly diagnosed AML. The -7+3- (ara-C plus daunorubicin) treatment has been used to treat newly diagnosed AML for over 30 years and is accepted as conventional or standard chemotherapy. Recently the dose of daunorubicin given has been increased in clinical trials. These clinical trials have shown increased response rates, without increased side effects. However we will monitor participants closely for increased heart and mouth ulcer side effects, the most common serious side effects. For patients under the age of 60 who have AML without high risk features the complete remission rate is 55-70%. However, for patients who are 60 or older, and/or whose AMLs have 1 or more high risk features, the remission rate is lower. Three separate studies giving FLAM to adults up to age 70 and/or with high risk features have produced complete remission rates over 60%. We want to find out if FLAM will improve the remission rate in comparison to -7+3-. Flavopiridol is an investigational drug. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). The FDA is allowing the use of flavopiridol in this study.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
Tumor Types: All Adults age > 18 years and < 70 years with Newly Diagnosed, Intermediate Risk or Poor-Risk AML.
Performance Status: ECOG Performance Status 0-3, patients > 65 years of age must have ECOG performance status < 2 prior to developing leukemic symptoms. Organ Function Low blood cell counts (ie, platelets, RBC's, WBC's)are allowed Normal kidney and liver function required Normal heart function required Allowed Prior Therapy: Hydroxyurea, non-cytotoxic therapy for MDS or MPN (e.g., thalidomide or lenalidomide, interferon, cytokines, 5-azacytidine or decitabine, histone deacetylase inhibitors, low-dose cytoxan, tyrosine kinase or dual TK/src inhibitors) will be eligible for this trial.
Patients cannot have been treated previously with flavopiridol. Patients cannot be diagnosed with core-binding factor AML's. Patients cannot have APL, >50,000blasts/uL, Patients cannot have simultaneous treatment with other chemotherapy, radiation, or immunotherapy.
Patient cannot have uncontrolled infection Patient cannot have active CNS leukemia, active GVHD, or other life threatening illnesses.
The patient cannot be pregnant or nursing.