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


Phase 2
18 Years
74 Years
Open (Enrolling)
Both
Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Refractory Anemia With Excess Blasts, Untreated Adult Acute Myeloid Leukemia

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Trial Information

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


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 could
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) four times daily (QID) 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.


Inclusion Criteria:



- Histologically or cytologically confirmed diagnosis of acute myeloid leukemia by
World Health Organization (WHO) 2008 criteria (except acute promyelocytic leukemia),
or myelodysplastic syndrome refractory anemia with excess blasts (RAEB)-2 by WHO
classification or advanced myeloproliferative neoplasm with >= 10% blasts in the bone
marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML) CMML-2
by WHO 2008 classification

- Untreated AML or high-risk myelodysplastic syndrome (MDS) and a simplified TRM score
of =< 9.2

- Bilirubin < 2.0 mg/ml

- Any creatinine value is acceptable, since this value is incorporated in the TRM and
an elevated creatinine is not an issue with idarubicin or cytarabine on a continuous
infusion schedule

- Any performance status is eligible, since it is also incorporated in the TRM score

- Life expectancy otherwise > 1 year

- Previous data reports a < 2% incidence of clinical cardiotoxicity with idarubicin
even at cumulative doses >= 175mg/m^2 in patients who have never received
anthracyclines; since idarubicin associated cardiotoxicity rarely occurs until
cumulative doses are much higher than those proposed in this trial, we will not
exclude patients base on cardiac history

- Females of childbearing potential must have a negative serum pregnancy test within 2
weeks prior to enrollment

- Patients must use an effective contraceptive method during the study and for a
minimum of 90 days after study treatment

- Capable of understanding the investigational nature, potential risks and benefits of
the study, and able to provide valid informed consent

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of participants with good CR

Outcome Description:

A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used.

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Raya Mawad

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Federal Government

Study ID:

2674.00

NCT ID:

NCT01831232

Start Date:

May 2013

Completion Date:

Related Keywords:

  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Monoblastic Leukemia (M5a)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloblastic Leukemia With Maturation (M2)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Acute Myelomonocytic Leukemia (M4)
  • Adult Erythroleukemia (M6a)
  • Adult Pure Erythroid Leukemia (M6b)
  • Chronic Myelomonocytic Leukemia
  • de Novo Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Refractory Anemia With Excess Blasts
  • Untreated Adult Acute Myeloid Leukemia
  • Congenital Abnormalities
  • Anemia
  • Anemia, Refractory
  • Anemia, Refractory, with Excess of Blasts
  • Neoplasms
  • Leukemia
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109