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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Myelogenous Leukemia

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Trial Information

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


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).

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The rate of complete remission (CR) after 1 cycle of induction therapy

Outcome Description:

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)

Outcome Time Frame:

1 cycle, approximately 6 weeks

Safety Issue:

No

Principal Investigator

Judith Karp, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Authority:

United States: Food and Drug Administration

Study ID:

NCI 8972 (JHOC 1101)

NCT ID:

NCT01413880

Start Date:

May 2011

Completion Date:

Related Keywords:

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

Name

Location

SKCCCBaltimore, Maryland  21287