Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML) - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	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.

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 II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

MedlinePlus related topics: Acute Myeloid Leukemia Cancer Leukemia

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:

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 Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Idarubicin + Cytarabine	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®

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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.

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
UT MD 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

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:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00422591 History of Changes
Other Study ID Numbers:	2006-0813
Study First Received:	January 16, 2007
Last Updated:	December 12, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Cytarabine, Idarubicin
Leukemia
Acute Myeloid Leukemia

AML
Cytarabine
Idarubicin

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on February 09, 2012