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Alvocidib (Flavopiridol), Ara-C and Mitoxantrone (FLAM) Versus "7+3" for Newly (AML) (FlAM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01413880
First received: May 5, 2011
Last updated: November 25, 2014
Last verified: November 2014

May 5, 2011
November 25, 2014
May 2011
July 2013   (final data collection date for primary outcome measure)
The rate of complete remission (CR) after 1 cycle of induction therapy [ Time Frame: 1 cycle, approximately 6 weeks ] [ Designated as safety issue: No ]
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)
To compare the rate of complete remission (CR) after 1 cycle of induction therapy [ Time Frame: 1 cycle, approvimately 6 weeks ] [ Designated as safety issue: No ]
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)
Complete list of historical versions of study NCT01413880 on ClinicalTrials.gov Archive Site
  • Safety [ Time Frame: 1 cycle, approximately 6 weeks ] [ Designated as safety issue: Yes ]
    Toxicities of FLAM vs. 7+3 after 1 cycle of therapy
  • survival [ Time Frame: 2 years for disease free survial, indefinately for overall survival ] [ Designated as safety issue: No ]
    2-year disease-free survival (DFS) and overall survival (OS) in response to FLAM vs. 7+3
  • Safety [ Time Frame: 1 cycle, approximately 6 weeks ] [ Designated as safety issue: Yes ]
    To evaluate and compare the toxicities of FLAM vs. 7+3 afer 1 cycle of therapy
  • survival [ Time Frame: 2 years for disease free survial, indefinately for overall survival ] [ Designated as safety issue: No ]
    To compare the 2-year disease-free survival (DFS) and overall survival (OS) in response to FLAM vs. 7+3
Not Provided
Not Provided
 
Alvocidib (Flavopiridol), Ara-C and Mitoxantrone (FLAM) Versus "7+3" for Newly (AML)
Timed Sequential Therapy (TST) With Alvocidib (Flavopiridol), Ara-C and Mitoxantrone (FLAM) Versus "7+3" for Newly Diagnosed Acute Myelogenous Leukemia (AML)

Comparing flavopiridol with ara-C and mitoxantrone (FLAM) to traditional chemotherapy used to treat newly diagnosed AML of ara-C and daunorubicin (7+3).

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
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myelogenous Leukemia
  • Drug: FLAM
    Flavopiridol will be administered daily for 3 days by 60 minute intravenous (IV) beginning Day 1 Cytosine Arabinoside (ara-C) will be administered by continuous IV infusion beginning on Day 6 Mitoxantrone will be administered by IV infusion over 60-120 minutes on Day 9
    Other Name: alvocidib, arC, novanrone
  • Drug: 7&3
    • Cytosine arabinoside (ara-C) 100 mg/m2/day will be administered by continuous IV infusion for a total of 7 days beginning Day 1
    • Daunorubicin 90 mg/m2 /day will be administered IV over 30-60 minutes Days 1, 2, 3
    Other Name: ara-c, daunorubicin or idarubicin
  • Experimental: Arm A
    • Flavopiridol will be administered daily for 3 days by 60 minute intravenous (IV) beginning Day 1
    • Cytosine Arabinoside (ara-C) will be administered by continuous IV infusion beginning on Day 6
    • Mitoxantrone will be administered by IV infusion over 60-120 minutes on Day 9
    Intervention: Drug: FLAM
  • Active Comparator: Arm B
    • Cytosine arabinoside (ara-C) 100 mg/m2/day will be administered by continuous IV infusion for a total of 7 days beginning Day 1
    • Daunorubicin 90 mg/m2 /day will be administered IV over 30-60 minutes Days 1, 2, 3
    Intervention: Drug: 7&3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
165
December 2015
July 2013   (final data collection date for primary outcome measure)

Inclusion:

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.

Exclusion Criteria:

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01413880
NCI 8972 (JHOC 1101), NA_00045631
No
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Not Provided
Study Chair: Judith Karp, MD The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sidney Kimmel Comprehensive Cancer Center
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP