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

Acute Myelogenous Leukemia Clinical Trial

— FlAM  

Official title:

Timed Sequential Therapy (TST) With Alvocidib (Flavopiridol), Ara-C and Mitoxantrone (FLAM) Versus "7+3" for Newly Diagnosed Acute Myelogenous Leukemia (AML)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01413880
• Other study ID #: NCI 8972 (JHOC 1101)
• Secondary ID: NA_00045631
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 5, 2011
• Last updated: November 25, 2014
• Start date: May 2011
• Est. completion date: December 2015

Study information

• Verified date: November 2014
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 165
• Est. completion date: December 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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
• 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

Locations

Country	Name	City	State
United States	SKCCC	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Safety	Toxicities of FLAM vs. 7+3 after 1 cycle of therapy	1 cycle, approximately 6 weeks	Yes
Secondary	survival	2-year disease-free survival (DFS) and overall survival (OS) in response to FLAM vs. 7+3	2 years for disease free survial, indefinately for overall survival	No