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SWOG 0919   |   CC777
A Phase II Study of Idarubicin and Ara-C in Combination with Pravastatin for Poor-Risk Acute Myelogenous Leukemia

Disease(s)
Leukemia, Acute Myeloid (AML)
Hospital(s)
Main Campus
Phase(s)
Phase 2
Stage(s)
Type(s)
Therapeutic
Drug(s)
Cytosine Arabinoside
Idarubicin
Pravastatin

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Description

Objectives

  1. To test whether the complete remission (CR) rate (including CR with incomplete recovery [CRi]) in patients with relapsed acute myeloid leukemia (AML) treated with a combination of chemotherapy and pravastatin is sufficiently high to warrant Phase III investigation.
  2. To estimate relapse-free survival and overall survival rates in this group of patients.
  3. To estimate the frequency and severity of toxicities of this regimen in this group of patients.
  4. To evaluate in a preliminary manner whether prestudy cytogenetic features correlate with response in this group of patients.

Inclusion Criteria

Induction

  1. For patients registered to the relapsed/refractory cohort, patients must have a previous morphologically confirmed diagnosis of acute myeloid leukemia (AML). For patients registered to the MDS transformed to AML cohort, patients must have a previous morphologically confirmed diagnosis of MDS. Patients may have received previous non-intensive therapy (e.g. azacitadine, decitabine, lowdose cytarabine (LDAC), lenalidomide) given for treatment of MDS (with up to 20% blasts). At the time of registration they must have a morphologically confirmed diagnosis of AML. Note: This protocol uses the WHO diagnostic criteria for AML (see protocol Section 4.1). Patients with acute promyelocytic leukemia (APL, FAB, M3) or blastic transformation of chronic myelogenous leukemia are not eligible.
  2. Patients in the relapsed/refractory AML cohort must meet all of the following criteria: Patients must have received at least one prior Induction chemotherapy regimen for their AML and they may have received any type of chemotherapy, administration of hydroxyurea to control high WBC prior to, during, and after registration is permitted. Relapse or refractory disease 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 chemotherapy within 14 days prior to registration; Patient must NOT have received autologous or allogeneic stem cell transplantation
  3. Primary refractory patients will be eligible if, on Day 14 of their previous chemotherapy regimen, they have significant residual disease. Patients who received only hypomethyl-ating agent or low dose therapy for Induction are not considered primary refractory for purposes of this study and are not eligible.
  4. Relapsed patients must have achieved a complete remission (CR) or CR with incomplete blood count recovery (CRi) lasting < 6 months with their last induction regimen.
  5. Patients must not have symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias. Either an echocardiogram or MUGA scan with an ejection fraction ≥ 45% must be obtained within 28 days prior to registration. (Either method for measuring cardiac function is acceptable, however, the same scan must be used throughout treatment and follow-up to monitor the patient for cardiac toxicity.) If patient has symptoms suggestive of ischemia or congestive heart failure after that cardiac evaluation was done, a repeat study must be obtained prior to registration.
  6. Patients must have a serum creatinine < 2.0 mg/dl within 14 days prior to registration.
  7. Patients must have a total bilirubin ≤ 2.0 x Institutional Upper Limit of Normal (IULN) within 14 days prior to registration, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert’s syndrome or hemolysis and not to liver dysfunction.
  8. Patients must have SGOT (AST) ≤ 3.0 x IULN and SGPT (ALT) ≤ 3.0 x IULN within 14 days prior to registration. Treatment may begin with SGOT/SGPT above those limits, if the abnormalities are thought to be due to the patient’s leukemia.
  9. Patients must have Zubrod performance status of 0-2 (see Section 10.8).
  10. Patients must be ≥ 18 years of age.
  11. Patients must not have clinical evidence of leptomeningeal disease (a spinal tap does not need to be performed).
  12. Patients not known to be HIV+ must be tested for HIV infection (the human immunodeficiency virus) within 14 days prior to registration (see Section 2.0 for justification). Patients who are HIV+ may be eligible providing they meet all of the following additional criteria within 14 days prior to registration:
    • Patient must have no history of AIDS defining events.
    • CD4 cells ≥ 500/mm³.
    • Viral load of < 50 copies HIV mRNA/mm³ if on cART or < 25,000 copies HIV mRNA if not on cART.
    • No zidovudine or stavudine as part of cART.
    Patients who are HIV+ and do not meet all of these criteria will not be eligible for this study.
  13. Patients with prior malignancy (other than AML) are eligible. However, the patient must be in remission from the prior malignancy and have completed all chemotherapy and radiotherapy at least 6 months prior to registration and all treatment related toxicities must have been resolved. NOTE: For patients with prior history of malignancy who have received anthracyclines or mediastinal/pericardial radiation in the past, the risk versus benefit of therapy should be weighed, particularly in the setting of receiving consolidation therapy.
  14. Patients must not have a systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
  15. Pretreatment cytogenetics must be performed on all patients. Collection of pretreatment specimens must be completed within 28 days prior to registration to 50919. Specimens must be submitted to the site's preferred cytogenetics laboratory (see Section 15.1).
  16. Women of reproductive potential must have a negative pregnancy test within 14 days prior to registration. Patients must not be pregnant or nursing because of the teratogenic potential of the drugs used in this study. Women/men of reproductive potential must have agreed to use an effective contraceptive method.
  17. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  18. At the time of patient registration, the treating institution’s name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base.

Consolidation

  1. Patients must have achieved CR as defined in Section 10.1c. Patients who achieved only CRi or PR, and patients who relapse from CR (Section 10.4) before this registration are not eligible.
  2. Patients must not have symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias. Either an echocardiogram or MUGA scan with an ejection fraction ≥ 45% must be obtained within 14 days prior to registration. (The same scan that was used during induction registration must be used for consolidation registration.) The ejection fraction must not have dropped ≥ 10% from the baseline ejection fraction. If patient has had symptoms suggestive of ischemia or congestive heart failure after that cardiac evaluation was done, a repeat study must be obtained prior to registration.
  3. Patients must have a serum creatinine < 2.0 mg/dl within 14 days prior to registration.
  4. Patients must have a total bilirubin ≤ 2.0 x Institutional Upper Limit of Normal (IULN) within 14 days prior to registration, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert’s syndrome or hemolysis and not to liver dysfunction.
  5. Patients must have SGOT (AST) ≤ 3.0 x IULN and SGPT (ALT) ≤ 3.0 x IULN within 14 days prior to registration.
  6. Patients must have Zubrod performance status of 0-2 (see Section 10.8).
  7. Patients must not have a systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
  8. Patients must have ANC ≥ 1,000/mcl and platelets ≥ 100,000/mcl within 7 days prior to registration.
  9. Patients must be registered to Consolidation therapy (Step 2) within 60 days of beginning Induction therapy (with Day 1 being the start of Induction).

Exclusion Criteria
Exclusion Criteria Not Available

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