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

NCT00422591 | Completed Phase 2 Results

• 2 other identifiers: 2006-0813NCI-2012-01412
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia; Acute Myeloid Leukemia; AML

Keywords

Cytarabine, Idarubicin; Leukemia; Acute Myeloid Leukemia; AML; Cytarabine; Idarubicin

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR) Rate

  Complete Response (CR): Normalization of marrow (\< 5% blasts; \>10% cellularity) and of peripheral blood counts (no circulating blasts, neutrophil count \> 109/L, platelet count \> 100 x 109/L).

  Up to 2 months

Secondary Outcomes (2)

• Event-Free Survival (EFS)

  from treatment initiation until treatment failure, relapse, or death

• Overall Survival (OS)

  Until death or loss of follow-up

Study Arms (1)

Idarubicin + Cytarabine

EXPERIMENTAL

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; Drug: Idarubicin

Interventions

Cytarabine DRUG

1.5 g/m2 IV over 24 hours daily on day 1-4 (age \<60 years) or days 1-3 (age \> 60 years).

Also known as: Ara-C, Cytosar-U

Idarubicin + Cytarabine

Idarubicin DRUG

12 mg/m2 IV over 1 hour daily x 3 (days 1-3)

Also known as: Idamycin®

Idarubicin + Cytarabine

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .
• Eastern Cooperative Oncology Group (ECOG) performance status (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 upper limit of normal (ULN)
• Ability to understand and provide signed informed consent.

You may not qualify if:

• 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, intrauterine device (IUD), diaphragm, abstinence, or condoms by their partner) over the entire course of the study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute

Interventions

Cytarabine; Idarubicin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Farhad Ravandi-Kashani, MD
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-7734

Study Officials

• Farhad Ravandi-Kashani, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 17, 2007
• Study Start: December 1, 2006
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: August 23, 2018
• Results First Posted: June 12, 2018

Record last verified: 2018-07

Locations

US (1)