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High Dose Chemotherapy, Peripheral Stem Cell Transplantation, and Interleukin-2 in Treating Patients With 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: NCT00002945
Recruitment Status : Completed
First Posted : April 16, 2003
Last Update Posted : April 13, 2012
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells.

PURPOSE: Phase III trial to study the effectiveness of high-dose combination chemotherapy, peripheral stem cell transplantation, and interleukin-2 in treating patients who have acute myeloid leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Biological: aldesleukin Biological: filgrastim Drug: cyclophosphamide Drug: cytarabine Drug: etoposide Drug: idarubicin Drug: melphalan Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy Phase 3

Detailed Description:


  • Determine relapse free survival of patients with previously untreated de novo or secondary acute myeloid leukemia treated with high dose cytarabine and idarubicin induction, high dose etoposide and cyclophosphamide intensification, filgrastim (G-CSF), melphalan, radiotherapy, autologous peripheral blood stem cell (PBSC) transplantation, and interleukin-2.
  • Correlate remission rate and relapse free survival with multidrug resistance phenotype in patients treated with this regimen.
  • Determine stem cell content and presence of cells with leukemia specific markers in PBSC harvested following high dose etoposide and cyclophosphamide intensification.
  • Correlate NK cell expansion (an increase in both proportion and absolute number) during interleukin-2 therapy following autologous PBSC transplantation with disease free survival.



  • Patients receive cytarabine IV over 1 hour every 12 hours for 6 days and idarubicin IV over 30 minutes following third, fifth, and seventh doses of cytarabine. Beginning 12 hours after the last dose of cytarabine, patients receive filgrastim (G-CSF) subcutaneously (SQ) each day until blood counts recover.


  • Patients receive etoposide IV over 34.3 hours followed 1 hour later by cyclophosphamide IV over 2 hours for 3 days. Beginning 24 hours after the last dose of cyclophosphamide, patients receive G-CSF SQ each day until blood counts recover.

Peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells. Patients receive melphalan IV over 1 hour on day -4 followed by total body irradiation on days -3, -2, and -1. PBSC are reinfused on day 0.

When blood counts recover, patients receive high dose interleukin-2 SQ on days 1-10 followed by low dose interleukin-2 SQ on days 11-13. Interleukin-2 treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with immunologic response to 6 courses of interleukin-2 treatment may continue for 6 additional courses.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study over 5 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-Dose Cytarabine and Idarubicin Induction, High Dose Etoposide and Cyclophosphamide Intensification, Autologous Stem Cell Transplantation and Interleukin-2 Immune Modulation in Previously Untreated De Novo and Secondary Adult Myeloid Leukemia
Study Start Date : December 1996
Actual Primary Completion Date : August 2001
Actual Study Completion Date : August 2011

Intervention Details:
  • Biological: aldesleukin
  • Biological: filgrastim
  • Drug: cyclophosphamide
  • Drug: cytarabine
  • Drug: etoposide
  • Drug: idarubicin
  • Drug: melphalan
  • Procedure: peripheral blood stem cell transplantation
  • Radiation: radiation therapy
    delivered to the cancer cells

Primary Outcome Measures :
  1. To determine the efficacy of 4-6 h and 18-24 h, 20% ALA applications on superficial and nodular epidermally-derived lesions using ca633 nm laser irradiation. [ Time Frame: 24 hours ]
    To determine the efficacy of 4-6 h and 18-24 h, 20% ALA applications on superficial and nodular epidermally-derived lesions using ca633 nm laser irradiation.

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven de novo or secondary acute myeloid leukemia with a classification of M0-M2 or M4-M7

    • No classification of M3
    • No promyelocytic leukemia
  • Prior medical conditions allowed:

    • Myelodysplastic syndromes
    • Aplastic anemia
    • Paroxysmal nocturnal hemoglobinuria
    • Myeloproliferative disorders except Philadelphia chromosome positive chronic myelogenous leukemia



  • Over 25

Performance status:

  • Not specified

Life expectancy:

  • At least 4 weeks


  • Not specified


  • Bilirubin no greater than 2 times normal
  • SGOT no greater than 2 times normal
  • Alkaline phosphatase no greater than 2 times normal


  • Creatinine no greater than 1.5 times normal


  • Ejection fraction at least 45%
  • No severe cardiovascular disease including myocardial infarction within past 6 months, uncontrolled symptomatic congestive heart failure, angina pectoris, or multifocal cardiac arrhythmias


  • No uncontrolled diabetes mellitus
  • No other active malignancy
  • No hypersensitivity to E. coli derived drug preparations


Biologic therapy:

  • Not specified


  • No prior chemotherapy for acute leukemia except hydroxyurea
  • Prior chemotherapy allowed for other malignancy or other medical condition

Endocrine therapy:

  • Not specified


  • Prior radiotherapy allowed for other malignancy or other medical condition


  • 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): NCT00002945

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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
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Study Chair: Meir Wetzler, MD Roswell Park Cancer Institute
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Responsible Party: Roswell Park Cancer Institute Identifier: NCT00002945    
Other Study ID Numbers: CDR0000065406
First Posted: April 16, 2003    Key Record Dates
Last Update Posted: April 13, 2012
Last Verified: April 2012
Keywords provided by Roswell Park Cancer Institute:
untreated adult acute myeloid leukemia
adult acute monoblastic leukemia and acute monocytic leukemia (M5)
adult acute erythroid leukemia (M6)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myelomonocytic leukemia (M4)
adult acute megakaryoblastic leukemia (M7)
secondary acute myeloid leukemia
adult acute minimally differentiated myeloid leukemia (M0)
Additional relevant MeSH terms:
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Leukemia, Myeloid
Neoplasms by Histologic Type
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antibiotics, Antineoplastic