Clinical Trial: Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Idarubicin, Cytarabine and Pravastatin (IAP) for Induction of Newly Diagnosed Acute Myeloid Leukemia (AML)

Brief Summary: This clinical trial studies idarubicin, cytarabine, and pravastatin sodium in treating patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin sodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving idarubicin and cytarabine together with pravastatin sodium may kill more cancer cells.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To assess the rate of achieving a "good complete response (CR)" after treating patients with newly diagnosed acute myeloid leukemia (AML) with idarubicin, cytarabine and pravastatin (pravastatin sodium) (IAP).

II. To determine the toxicity (death within 28 days of starting therapy = treatment related mortality or "TRM") with IAP in newly-diagnosed AML.

SECONDARY OBJECTIVES:

I. To determine rates of complete remission (CR), remission with incomplete blood count recovery (CRi), partial remission (PR), relapse-free survival and overall survival.

II. To identify biomarkers (ie. changes in serum cholesterol) associated with clinical responses.

OUTLINE:

Patients receive pravastatin sodium orally (PO) once daily (QD) on days 1-8, idarubicin intravenously (IV) over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then annually for 3 years.


Sponsor: Fred Hutchinson Cancer Research Center

Current Primary Outcome:

  • Number of participants with good CR [ Time Frame: Up to 5 years ]
    A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used.
  • Number of participants with TRM [ Time Frame: 28 days ]
    A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used.


Original Primary Outcome:

  • Number of participants with good complete response (CR) rate [ Time Frame: Up to 5 years ]
    A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used.
  • Number of participants with transplant related mortality (TRM) [ Time Frame: 28 days ]
    A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used.


Current Secondary Outcome:

  • Relapse free survival [ Time Frame: Amount of time a patient lives in the absence of disease after treatment with IAP, assessed up to 5 years ]
  • Overall survival [ Time Frame: Amount of time a patient lives after treatment with IAP, assessed up to 5 years ]
  • Biomarkers associated with clinical responses [ Time Frame: Days 17-20, 24-27, and 31-38 ]


Original Secondary Outcome:

Information By: Fred Hutchinson Cancer Research Center

Dates:
Date Received: April 8, 2013
Date Started: May 2013
Date Completion:
Last Updated: March 3, 2015
Last Verified: March 2015