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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
  Purpose

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


Condition Intervention Phase
Acute Myelogenous Leukemia
Drug: FLAM
Drug: 7&3
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Timed Sequential Therapy (TST) With Alvocidib (Flavopiridol), Ara-C and Mitoxantrone (FLAM) Versus "7+3" for Newly Diagnosed Acute Myelogenous Leukemia (AML)

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 165
Study Start Date: May 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413880

Locations
United States, Maryland
SKCCC
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Judith Karp, MD The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01413880     History of Changes
Other Study ID Numbers: NCI 8972 (JHOC 1101), NA_00045631
Study First Received: May 5, 2011
Last Updated: November 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Alvocidib
Cytarabine
Daunorubicin
Mitoxantrone
Analgesics
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Central Nervous System Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Sensory System Agents
Therapeutic Uses
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014