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S0919, A Phase II Study of Idarubicin and Ara-C in Combination With Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)

Phase 2
18 Years
Open (Enrolling)

Thank you

Trial Information

S0919, A Phase II Study of Idarubicin and Ara-C in Combination With Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)


- To test whether the complete remission (CR) rate (including CR with incomplete
recovery) in patients with relapsed acute myeloid leukemia treated with idarubicin and
cytarabine in combination with pravastatin is sufficiently high to warrant a phase III

- To estimate relapse-free survival and overall survival rates in these patients.

- To estimate the frequency and severity of toxicities of this regimen in these patients.

- To evaluate, in a preliminary manner, whether pre-study cytogenetic features correlate
with response in these patients.

OUTLINE: This is a multicenter study.

- Induction therapy: Patients receive oral pravastatin once daily on days 1-8, idarubicin
IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Patients
achieving complete remission proceed to consolidation therapy.

- Consolidation therapy: Beginning 30-60 days after the start of induction therapy,
patients receive oral pravastatin once daily on days 1-6 and idarubicin IV over 10-15
minutes and cytarabine IV continuously on days 4 and 5. Treatment repeats approximately
every 5 weeks for up to 2 courses in the absence of disease progression or unacceptable

After completion of study treatment, patients are followed periodically for 5 years.

Inclusion Criteria


- Morphologically confirmed diagnosis of acute myeloid leukemia (AML)

- Must have received ≥ 1 prior chemotherapy regimen for AML

- Any type of prior chemotherapy allowed

- Must have achieved a complete remission (CR) (including CR with incomplete
recovery) that lasted ≥ 3 months after the last induction regimen and then
subsequently relapsed

- Relapse must be documented by a bone marrow examination demonstrating > 5%
blasts in the bone marrow not attributable to another cause

- No acute promyelocytic leukemia (i.e., APL, FAB M3) or blastic transformation of
chronic myelogenous leukemia

- No clinical evidence of leptomeningeal disease

- Concurrent registration on research study SWOG-9007 required


- Zubrod performance status 0-2

- Serum creatinine ≤ 2.0 times upper limit of normal (ULN)

- Total bilirubin ≤ 2.0 times ULN (unless elevation is primarily due to elevated
unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis AND not
due to liver dysfunction)

- AST and ALT ≤ 3.0 times ULN

- Ejection fraction ≥ 45% by echocardiogram or MUGA scan

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or
uncontrolled arrhythmias

- No HIV positivity unless the following criteria are met:

- No history of AIDS-defining events

- CD4 count ≥ 500/mm³

- Viral load < 25,000 copies (< 50 copies if on combination antiretroviral

- Not receiving zidovudine or stavudine as part of combination antiretroviral

- No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as
exhibiting ongoing signs/symptoms related to the infection with no improvement
despite appropriate antibiotics or other treatment

- Other prior malignancy allowed provided patient is in remission from that malignancy


- See Disease Characteristics

- At least 6 months since prior chemotherapy or radiotherapy and recovered

- No prior autologous or allogeneic stem cell transplantation

- Prior or concurrent hydroxyurea to control high WBC counts allowed

- No concurrent statin treatments

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission (CR) rate (including CR with incomplete recovery)

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Anjali Advani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




Start Date:

August 2009

Completion Date:

November 2015

Related Keywords:

  • Leukemia
  • recurrent adult acute myeloid leukemia
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



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