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S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Southwest Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00840177
First received: February 7, 2009
Last updated: April 4, 2014
Last verified: April 2014

February 7, 2009
April 4, 2014
August 2009
June 2017   (final data collection date for primary outcome measure)
  • Complete remission (CR) rate (including CR with incomplete recovery) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Relapse-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE version 4.0 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Correlation between pre-study cytogenetic features and response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Complete remission (CR) rate (including CR with incomplete recovery) [ Designated as safety issue: No ]
  • Relapse-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE version 3.0 [ Designated as safety issue: Yes ]
  • Correlation between post-treatment cholesterol levels, pre-study cytogenetic features, and response [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00840177 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia
S0919, A Phase II Study of Idarubicin and Ara-C in Combination With Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)

RATIONALE: 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 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pravastatin may also help idarubicin and cytarabine work better by making cancer cells more sensitive to the drugs. Giving idarubicin and cytarabine together with pravastatin may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together with pravastatin works in treating patients with relapsed acute myeloid leukemia.

OBJECTIVES:

  • 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 investigation.
  • 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 toxicity.

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

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia
  • Drug: cytarabine
  • Drug: idarubicin
  • Drug: pravastatin sodium
Experimental: treatment

Induction (1 cycle):

pravastatin 1280 mg/d PO D 1-8 idarubicin 12 mg/m2/d IV D 4-6 AraC 1.5 g/m2/d contIV D 4-7

Consolidation (up to 2 cycles):

pravastatin 1280 mg/d PO D 1-6 idarubicin 12 mg/m2/d IV D 4-5 AraC 1.5 g/m2/d contIV D 4-5

Interventions:
  • Drug: cytarabine
  • Drug: idarubicin
  • Drug: pravastatin sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
February 2018
June 2017   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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 therapy)
    • Not receiving zidovudine or stavudine as part of combination antiretroviral therapy
  • 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

PRIOR CONCURRENT THERAPY:

  • 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
Both
18 Years and older
No
Contact: Sandi J Fredette 2106148808 ext 1002 sfredette@swog.org
Contact: Dana Sparks, MAT 2106148808 ext 1004 dsparks@swog.org
United States
 
NCT00840177
CDR0000633749, S0919, U10CA032102
Yes
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Anjali Advani, MD The Cleveland Clinic
Southwest Oncology Group
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP