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

This study is currently recruiting participants.

Verified by M.D. Anderson Cancer Center, December 2008

First Received: January 16, 2007 Last Updated: December 10, 2008 History of Changes

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00422591

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.

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Cytarabine hydrochloride Idarubicin hydrochloride Idarubicin Cytarabine

U.S. FDA Resources

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

Primary Outcome Measures:

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. [ Time Frame: October 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	December 2006
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Idarubicin + Cytarabine	Drug: Cytarabine 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: Idarubicin Idarubicin 12 mg/m2 IV over 1 hour daily x 3 (days 1-3)

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Eligibility

Ages Eligible for Study:	15 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of 1) AML (WHO classification definition of >/= 20% blasts). Patients with M6 AML with less than 20% blasts are eligible.
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 .
ECOG PS of 0, 1, 2, or 3 at screening.
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
Ability to understand and provide signed informed consent.

Exclusion Criteria:

Subjects with Acute Promyelocytic Leukemia (APL).
Presence of active systemic infection.
Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
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.study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422591

Contacts

Contact: Farhad Ravandi-Kashani, MD

713-745-0394

Locations

United States, Texas
U.T. M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Farhad Ravandi-Kashani, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Farhad Ravandi-Kashani, MD

U.T. M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson's Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	The University of Texas M. D. Anderson Cancer Center ( Farhad Ravandi-Kashani, M.D./Associate Professor )
Study ID Numbers:	2006-0813
Study First Received:	January 16, 2007
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00422591 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Cytarabine, Idarubicin
Leukemia
Acute Myeloid Leukemia

AML
Cytarabine
Idarubicin

Study placed in the following topic categories:

Antimetabolites
Anti-Bacterial Agents
Leukemia
Idarubicin
Acute Myelocytic Leukemia
Immunologic Factors

Leukemia, Myeloid
Leukemia, Myeloid, Acute
Immunosuppressive Agents
Antiviral Agents
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia, Myeloid
Antibiotics, Antineoplastic

Leukemia, Myeloid, Acute
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Leukemia
Neoplasms
Idarubicin
Therapeutic Uses
Cytarabine

ClinicalTrials.gov processed this record on July 02, 2009