Alvocidib (Flavopiridol), Ara-C and Mitoxantrone (FLAM) Versus "7+3" for Newly (AML) (FlAM)
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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) |
- 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)
- 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 Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
Experimental: Arm A
|
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
|
Drug: 7&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 |
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| United States, Maryland | |
| SKCCC | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Judith Karp, MD 410-502-7726 crocsm@jhmi.edu | |
| 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: | May 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cytarabine Flavopiridol Daunorubicin Mitoxantrone Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Growth Inhibitors Growth Substances Protein Kinase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013