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

Phase 2

Completed

Conditions: Leukemia

Interventions: Drug: Azacitidine

Registration Number: NCT00387647

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description: Patient activity will encompass approximately 48 months: an approximate 24 month enrollment period, followed by 6 to 12 months of patient treatment. Patients will be followed for 1 year following completion of study drug treatment. During follow-up, bone marrow biopsies to confirm disease status should be obtained if peripheral blood blasts are present or if there is development of unexpected blood abnormalities to warrant suspicion of relapse, or at a minimum of every 6 months.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Azacitidine Treatment	Azacitidine	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.

Primary Outcome Measures

Name	Time	Method
Rate of Disease Free Survival at One Year	1 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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	48 months	The secondary efficacy variable is overall survival measured as time to death, which is the time from remission until death from any cause.
Number of Participants With Adverse Events	48 months	Safety and tolerability of treatment as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Trial Locations

Locations (2): H. Lee Moffitt Cancer Center and Research Institute
🇺🇸
Tampa, Florida, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States