Randomized Study of Decitabine in Maintenance Therapy of Acute Myeloid Leukemia (AML)

NCT00398983 | Completed Phase 2 Results DMC

• 1 other identifier: 2006-0358
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to find out whether continued therapy with decitabine after achieving a remission in acute myeloid leukemia (AML) patients can help prolong the remission and prevent relapse of the disease.

Conditions

Acute Myelogenous Leukemia

Keywords

Acute Myelogenous Leukemia; AML; Remission; Decitabine; Maintenance Therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Relapse-Free Response at 1 Year

  Relapse free response defined an absence of relapse at one year of follow up.

  Baseline to 1 year

Study Arms (2)

Decitabine 20 mg/m^2

EXPERIMENTAL

20 mg/m\^2 intravenous (IV) daily for 5 days

Drug: Decitabine

No Study Drug

NO INTERVENTION

Continue current therapy.

Interventions

Decitabine DRUG

20 mg/m\^2 IV over 1 hour daily for 5 days

Also known as: Dacogen

Decitabine 20 mg/m^2

Eligibility Criteria

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

You may qualify if:

• Adult patients (greater than 18 years) with acute myelogenous leukemia (AML) by World Health Organization (WHO) criteria (greater than 20% blasts) and unfavorable risk cytogenetics (including intermediate and poor risk categories) in first CR or complete remission without full platelet recovery (CRp)
• Adult patients (greater than 18 years) in second or subsequent Complete Response (CR) (or CRp)
• Performance status of 0, 1, or 2
• Adequate organ function with creatinine less than or equal to 2.0 mg/dL, bilirubin less than or equal to 3.5 mg/dL and aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) less than or equal to 3 times institutional upper limit of normal

You may not qualify if:

• Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization
• Known to be HIV+
• Active and uncontrolled disease/infection as judged by the treating physician
• Unable or unwilling to sign the consent form
• No other investigational therapy within the past 14 days

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Eisai Inc.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M.D. Anderson's website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Decitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Farhad Ravandi-Kashani, MD / Associate Professor
• Organization: The University of Texas MD Anderson Cancer Center

eharrison@mdanderson.org

713-745-0394

Study Officials

• Farhad Ravandi-Kashani, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 14, 2006
• Study Start: August 1, 2006
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 4, 2013
• Results First Posted: March 4, 2013

Record last verified: 2013-01

Locations

US (1)