Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML)
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00422591
First received: January 16, 2007
Last updated: November 6, 2012
Last verified: November 2012
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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: | 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 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
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:
Drug: Idarubicin
12 mg/m2 IV over 1 hour daily x 3 (days 1-3)
Other Name: Idamycin®
|
Show Detailed Description 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
Locations
| United States, Texas | |
| UT 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:
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: | November 6, 2012 |
| 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 May 16, 2013