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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: January 16, 2007
Last updated: November 9, 2016
Last verified: November 2016

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.


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
Acute Myeloid Leukemia
Drug: Cytarabine
Drug: Idarubicin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Event-Free Survival (EFS) [ Time Frame: October 2010 ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: October 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2006
Estimated Primary Completion Date: October 2018 (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


Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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. 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 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, IUD, diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00422591

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00422591     History of Changes
Other Study ID Numbers: 2006-0813  NCI-2012-01412 
Study First Received: January 16, 2007
Last Updated: November 9, 2016
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
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 processed this record on December 05, 2016