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Idarubicin and High-Dose Cytarabine 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.
 
ClinicalTrials.gov Identifier: NCT00528398
Recruitment Status : Completed
First Posted : September 12, 2007
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Study Description
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Brief Summary:

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. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.


Condition or disease Intervention/treatment Phase
Leukemia Drug: cytarabine Drug: idarubicin Phase 2

Detailed Description:

OBJECTIVES:

  • Determine the complete remission rate (CR).
  • Determine the proportion of patients who are bone marrow-positive at day 7 post-induction chemotherapy.
  • Further evaluate the toxicity of this regimen.

OUTLINE: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or > 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Utilizing Idarubicin in Combination With High Dose Ara-C for Induction Therapy for Adult Acute Myelogenous Leukemia (AML)
Study Start Date : September 1994
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (idarubicin, cytarabine)
Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or > 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.
 Drug: cytarabine
Other Names:
  • Cytosine Arabinoside
  • Cytosar-U
  • Depocyt

Drug: idarubicin
Other Names:
  • 4-demethoxydaunorubicin
  • Idamycin
  • Zavedos


Outcome Measures
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Primary Outcome Measures :
  1. Complete Remission (CR) [ Time Frame: 7 days post completion of induction chemotherapy ]
    The peripheral blood neutrophil count is >= 1.5 x 10^9 / L and platelets more than 100 x 10^9 / L. Leukemia blast cells are not present in the peripheral blood. The cellularity of the bone marrow is more than 20% with maturation of all cell lines. The bone marrow contains less than 5% blast cells, and Auer rods is not detectable.


Secondary Outcome Measures :
  1. Bone Marrow at Day 7 Post-Induction Chemotherapy [ Time Frame: 7 days post completion of induction chemotherapy ]
    Bone marrow positive, negative cells at day 7 post-induction chemotherapy for leukemia (%)


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Newly diagnosed acute myeloid leukemia (AML)

    • Morphologic proof (bone marrow aspirate smears or touch prep of marrow biopsy) of disease
    • FAB M0, M1, M2, M4, M5a, M5b, M6a, M6b, and M7 disease

  • Previously untreated with radiotherapy or chemotherapy

    • Patients with treatment-related leukemia are eligible even if they have received prior chemotherapy and radiotherapy
  • Patients with prior myelodysplastic syndrome are eligible
  • Extramedullary leukemia allowed
  • AML with lymphoid markers allowed

Exclusion criteria:

  • Blastic transformation of chronic myelogenous leukemia
  • Biphenotypic leukemia
  • FAB M3 disease (acute promyelocytic leukemia)

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 6 weeks
  • Total bilirubin < 1.5 g/dL
  • AST and ALT < 5 times upper limit of normal (ULN)
  • Creatinine < 1.5 mg/dL OR creatinine clearance > 70 mL/min
  • Ejection fraction ≥ 50% by MUGA unless decreased ejection fraction is secondary to leukemia infiltration
  • HIV antibody-negative

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • See Disease Characteristics
  • Prior hydroxyurea or corticosteroids allowed
  • At least 48 hours since prior and no concurrent itraconazole or fluconazole

Exclusion criteria:

  • More than 300 mg/m² of prior daunorubicin or equivalent dose of anthracycline
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00528398


Locations
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United States, Arizona
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Anthony S. Stein, MD City of Hope Comprehensive Cancer Center
More Information
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00528398    
Other Study ID Numbers: 93139
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-93139
CHNMC-93139-94-03-1
CDR0000564537 ( Registry Identifier: NCI PDQ )
First Posted: September 12, 2007    Key Record Dates
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017
Last Verified: December 2016
Keywords provided by City of Hope Medical Center:
adult acute megakaryoblastic leukemia (M7)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myelomonocytic leukemia (M4)
adult erythroleukemia (M6a)
 adult pure erythroid leukemia (M6b)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
secondary acute myeloid leukemia
untreated adult acute myeloid leukemia
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
 Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors