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S0301 Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00066794
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : March 6, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as cyclosporine, daunorubicin, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving cyclosporine together with daunorubicin and cytarabine works in treating older patients with untreated acute myeloid leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Biological: filgrastim Biological: sargramostim Drug: cyclosporine Drug: cytarabine Drug: daunorubicin hydrochloride Phase 2

Detailed Description:


  • Determine the safety and efficacy of cyclosporine, daunorubicin, and cytarabine in older patients with previously untreated acute myeloid leukemia.
  • Determine the frequency and severity of toxic effects of this regimen in these patients.
  • Determine, preliminarily, the frequency and prognostic significance of functional and phenotypic P-glycoprotein expression and cytogenetics in patients treated with this regimen.
  • Determine, preliminarily, the pharmacokinetic characteristics of this regimen in these patients.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive cyclosporine IV and daunorubicin IV continuously on days 1-3 and cytarabine IV continuously on days 1-7. Patients who achieve complete response (CR) after chemotherapy receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously beginning on day 15 or 20 and continuing until blood counts recover. Patients who maintain CR after 2 courses of induction therapy proceed to consolidation therapy.
  • Consolidation therapy: Patients receive treatment as in induction therapy with cyclosporine and daunorubicin on days 1-2 and cytarabine on days 1-5. Patients achieving CR receive an additional course of chemotherapy beginning at least 14 days after completion of the first course of cytarabine.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 25-64 patients will be accrued for this study within 13 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Induction With Daunorubicin, Cytarabine, And Cyclosporine All By Continuous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) In Patients Of Age 56 Or Older
Study Start Date : July 2004
Actual Primary Completion Date : February 2007
Actual Study Completion Date : January 2010

Intervention Details:
  • Biological: filgrastim
    5 mcg/kg/d IV or SC starting apx day 15
  • Biological: sargramostim
    250 mcg/kg/d IV or SC starting apx day 15
  • Drug: cyclosporine
    ind: 6 mg/kg load IV over 2 hrs days 0-2 followed by 16 mg/dg/d continuous IV days 2-74 consol: 6 mg/kg load IV over 2 hrs days 0-2 followed by 16 mg/dg/d continuous IV days 2-50
  • Drug: cytarabine
    ind: 200 mg/m2/d cont IV days 2-74
  • Drug: daunorubicin hydrochloride
    ind: 45 mg/m2/d cont IV days 2-74

Primary Outcome Measures :
  1. Complete remission (CR) [ Time Frame: After induction therapy is completed ]

Information from the National Library of Medicine

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Ages Eligible for Study:   56 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Morphologically confirmed acute myeloid leukemia (AML)

    • Differential diagnosis of AML based on FAB classification system

      • M0-M7 (No M3)
  • No blastic transformation of chronic myelogenous leukemia
  • Must be currently registered on protocols SWOG-9007 and SWOG-S9910



  • 56 and over

Performance status

  • Zubrod 0-3 (for patients 56 to 60 years of age) OR
  • Zubrod 0-2 (for patients 61 to 70 years of age) OR
  • Zubrod 0-1 (for patients 71 years of age and over)

Life expectancy

  • Not specified


  • Not specified


  • Bilirubin no greater than 2 times upper limit of normal (ULN) unless elevated unconjugated hyperbilirubinemia is secondary to Gilbert's syndrome or hemolysis and not to liver dysfunction
  • AST and/or ALT no greater than 4 times ULN


  • Creatinine no greater than 1.5 times ULN AND/OR
  • Creatinine clearance greater than 40 mL/min


  • Left ventricular function normal
  • Ejection fraction at least 50% by MUGA or echocardiogram
  • No unstable cardiac arrhythmias
  • No unstable angina


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in complete remission


Biologic therapy

  • No concurrent pegfilgrastim


  • At least 30 days since prior low-dose cytarabine (less than 100 mg/m^2/day) for myelodysplastic syndromes and recovered
  • Prior hydroxyurea to control high cell counts allowed
  • No prior systemic chemotherapy for acute leukemia
  • Concurrent single-dose intrathecal chemotherapy allowed

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00066794

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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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Principal Investigator: Thomas R. Chauncey, MD, PhD VA Puget Sound Health Care System
Principal Investigator: Cheryl L. Willman, MD University of New Mexico Cancer Center
Principal Investigator: Marilyn L. Slovak, PhD City of Hope Comprehensive Cancer Center
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Responsible Party: Southwest Oncology Group Identifier: NCT00066794    
Other Study ID Numbers: S0301
S0301 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2003    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Keywords provided by Southwest Oncology Group:
adult acute monocytic leukemia (M5b)
adult acute megakaryoblastic leukemia (M7)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
untreated adult acute myeloid leukemia
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult pure erythroid leukemia (M6b)
adult erythroleukemia (M6a)
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Enzyme Inhibitors
Antifungal Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors