Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia (AML) in CR After Induction Chemotherapy

NCT00387647 | Completed Phase 2 Results

• 1 other identifier: MCC-14496
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to find out if patients older than 60, with acute myeloid leukemia, who are in complete remission following initial chemotherapy, will live longer and have a lower rate of leukemia relapse when treated with azacitidine.

Conditions

Leukemia

Keywords

myeloid; acute; monocytic

Outcome Measures

Primary Outcomes (1)

• Rate of Disease Free Survival at One Year

  The primary efficacy variable is disease free survival measured at one year, which is the percentage of patients who remain alive and disease free one year after the confirmation of remission by bone marrow biopsy. Relapse is defined by a bone marrow specimen with \>5% blasts or the presence of Auer rods.

  1 year

Secondary Outcomes (2)

• Overall Survival (OS)

  48 months

• Number of Participants With Adverse Events

  48 months

Study Arms (1)

Azacitidine Treatment

EXPERIMENTAL

Azacitidine 50 mg/m\^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles.

Drug: Azacitidine

Interventions

Azacitidine DRUG

Azacitidine given subcutaneously as outlined in treatment arm.

Also known as: Vidaza™

Azacitidine Treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic or cytologic confirmation of AML with greater than 20% blasts in bone marrow. All AML subtypes of the World Health Organization (WHO) classification will be included with the exception of promyelocytic leukemia and cytogenetics showing the (15;17) translocation or AML secondary to chemotherapy.
• Achieved first morphologic complete remission (CR) or first morphologic complete remission with incomplete platelet recovery (CRp) after completion of induction chemotherapy using a standard induction regimen. Up to 2 induction cycles will be allowed. Confirmation of CR is defined as \< 5% blasts in the bone marrow specimen, with a count of at least 100-200 nucleated cells and absence of Auer rods, along with peripheral blood neutrophil count \>1.0 x 10\^9/L and platelet count \>100 x 10\^9/L. Confirmation of CRp is defined as \<5% blasts in the bone marrow specimen, with a count of at least 100-200 nucleated cells and absence of Auer rods, with incomplete platelet recovery (ANC ≥ 1000/µL and platelets 50-99,000/µL, along with transfusion-independence of red blood cells).
• Received up to 2 cycles of any consolidation chemotherapy
• Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• Normal organ function at the time of screening: Total bilirubin ≤1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤2.5 x ULN; Serum creatinine ≤1.5 x ULN or creatinine clearance \>60 mL/min for patients with creatinine levels above ULN
• Men must agree to avoid fathering a child throughout the study.
• Be capable of giving informed consent and have signed the informed consent form (ICF)

You may not qualify if:

• Greater than 12 weeks since initiation of most recent cycle of consolidation chemotherapy
• Women of childbearing potential
• Prior relapse after complete remission for AML
• AML secondary to previous exposure to cytotoxic chemotherapy known to induce leukemia
• Active malignancy other than AML
• Any diagnosis of metastatic disease
• Have hepatic tumors
• Radiation therapy, chemotherapy, or cytotoxic therapy, given to treat conditions other than AML \<4 weeks prior to Day 1 or have not recovered from adverse events due to agents administered \>4 weeks earlier
• Known leukemic involvement of the central nervous system
• Known or suspected hypersensitivity to azacitidine or mannitol
• Prior or active disease that, in the opinion of the Investigator, may interfere with the procedures or evaluations to be conducted in the study (uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements)
• Active viral infection with known human immunodeficiency virus (HIV) or viral hepatitis type B or C
• Treatment with other investigational drugs within the 30 days prior to Day 1, or ongoing adverse events from previous treatment with investigational drugs, regardless of the time period
• Any prior treatment with azacitidine or decitabine

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Celgene Corporation: collaborator

Study Sites (2)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Leukemia

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Only five participants completed study and defined follow-up period and one participant remained on follow-up at time of analysis.

Results Point of Contact

• Title: Jeffrey Lancet, M.D.
• Organization: H. Lee Moffitt Cancer Center and Research Institute

jeffrey.lancet@moffitt.org

813-745-6841

Study Officials

• Jeffrey E. Lancet, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  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: October 12, 2006
• First Posted: October 13, 2006
• Study Start: August 1, 2006
• Primary Completion: October 1, 2013
• Study Completion: August 1, 2014
• Last Updated: August 22, 2014
• Results First Posted: June 30, 2014

Record last verified: 2014-08

Locations

US (2)