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Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00422591
First Posted: January 17, 2007
Last Update Posted: January 19, 2017
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.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

The goal of this clinical research study is to find out if standard chemotherapy given with idarubicin and Cytarabine (ara-C) can help to control AML.

Objectives:

To determine the complete response (CR) rate, event-free survival (EFS) and overall survival (OS) of patients with newly diagnosed acute myeloid leukemia (AML) receiving standard combination chemotherapy with Idarubicin and cytarabine.


Condition Intervention Phase
Leukemia Acute Myeloid Leukemia AML Drug: Cytarabine Drug: Idarubicin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Standard Chemotherapy Regimen of Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Complete Response (CR) Rate [ Time Frame: October 2010 ]

Secondary Outcome Measures:
  • Event-Free Survival (EFS) [ Time Frame: October 2010 ]
  • Overall Survival (OS) [ Time Frame: October 2010 ]

Enrollment: 175
Study Start Date: December 2006
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Idarubicin + Cytarabine
Idarubicin 12 mg/m2 IV over 1 hour daily x 3 (days 1-3). Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years).
Drug: Cytarabine
1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years).
Other Names:
  • Ara-C
  • Cytosar-U
Drug: Idarubicin
12 mg/m2 IV over 1 hour daily x 3 (days 1-3)
Other Name: Idamycin®

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of 1) AML (WHO classification definition of >/= 20% blasts). Patients with M6 AML with less than 20% blasts are eligible.
  2. Patients aged 15 to 75 years are eligible. Patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for AML. They could have received transfusions, hematopoietic growth factors or vitamins. Temporary measures such as pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed .
  3. Eastern Cooperative Oncology Group (ECOG) PS of 0, 1, 2, or 3 at screening.
  4. Serum biochemical values with the following limits: - creatinine </= 2.0 mg/dl - total bilirubin </= 2.0 mg/dL, unless increase is due to hemolysis - transaminases (SG PT) </= 3x upper limit of normal (ULN)
  5. Ability to understand and provide signed informed consent.

Exclusion Criteria:

  1. Subjects with Acute Promyelocytic Leukemia (APL).
  2. Presence of active systemic infection.
  3. Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
  4. Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
  Contacts and Locations
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): NCT00422591


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Farhad Ravandi-Kashani, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00422591     History of Changes
Other Study ID Numbers: 2006-0813
NCI-2012-01412 ( Registry Identifier: NCI CTRP )
First Submitted: January 16, 2007
First Posted: January 17, 2007
Last Update Posted: January 19, 2017
Last Verified: January 2017

Keywords provided by M.D. Anderson Cancer Center:
Cytarabine, Idarubicin
Leukemia
Acute Myeloid Leukemia
AML
Cytarabine
Idarubicin

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
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