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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 November 2016 by Southwest Oncology Group
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00840177
First received: February 7, 2009
Last updated: November 4, 2016
Last verified: November 2016

February 7, 2009
November 4, 2016
August 2009
December 2018   (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
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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
July 2019
December 2018   (final data collection date for primary outcome measure)

Cohort 1 (MDS transformed to AML) is open to accrual

Cohort 2 (relapsed/refractory AML) is permanently closed to accrual

DISEASE CHARACTERISTICS:

  • For patients registered to relapsed/refractory (Cohort 2), morphologically confirmed diagnosis of acute myeloid leukemia (AML)
  • Patient registered to the MDS transformed to AML cohort (Cohort 1) patients must have a previous morphologically confirmed diagnosis of MDS/CMML. Patients may have received previous non-intensive therapy (such as: azacitadine, decitabine, low-dose cytarabine, lenalidomide) given treatment of MDS/CMML (with up to 20% blasts). At time of registration, patient must have morphologically confirmed diagnosis of AML.
  • Patients with acute promyelocytic leukemia (i.e., APL, FAB M3) or blastic transformation of chronic myelogenous leukemia are not eligible
  • Patients mus not have received autologous or allogeneic stem cell transplant.
  • Patients in the relapsed/refractory AML cohort (Cohort 2) must:

    • Have received ≥ 1 prior chemotherapy regimen for AML

      • Any type of prior chemotherapy allowed
      • Administration of hydroxyurea to control high WBC prior to, during, and after registration is permitted
    • Relapse must be documented by a bone marrow examination demonstrating > 5% blasts in the bone marrow not attributable to another cause
    • Patient must not have received chemo within 14 days prior to registration
  • Primary refractory patients eligible if, on Day 14 of previous chemo regimen, they have significant residual disease. Patients who received only hypomethylating agent or low dose therapy for Induction are not considered primary refractory for this study and are not eligible.
  • Relapsed patients must have achieved a complete remission (CR) or CR with incomplete blood count recovery that lasted < 6 months after the last induction regimen
  • No clinical evidence of leptomeningeal disease
  • Pretreatment (collected within 28 days of registration) cytogenetics must be performed on all patients.
  • Patients must have complete history and physical exam within 28 days prior to registration.

PATIENT CHARACTERISTICS:

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

    • Ejection fraction ≥ 45% by echocardiogram or MUGA scan within 28 days prior to registration (or within 14 days prior to registration if the patient has received anthracycline in the 28 day window)
  • 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
  • Not pregnant or nursing and negative pregnancy test within 14 days prior to registration. Females of child-bearing potential must agree to use effective contraception
  • 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
  • Patients with prior malignancy (other than AML and MDS/CMML) eligible provided patient is in remission from that malignancy at least 6 months prior to registration. Except for AML and MDS treatment, all treatment related toxicities must have been resolved.
Both
18 Years and older   (Adult, Senior)
No
Contact: Cara Laubach 2106148808 ext 1027 claubach@swog.org
Contact: Dana Sparks, MAT 2106148808 ext 1004 dsparks@swog.org
United States
 
NCT00840177
S0919, S0919, U10CA032102
Yes
Not Provided
Not Provided
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Anjali Advani, MD The Cleveland Clinic
Southwest Oncology Group
November 2016

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