Status:
COMPLETED
Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia (AML) in CR After Induction Chemotherapy
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Celgene Corporation
Conditions:
Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE2
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...
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 comp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00387647
Start Date
August 1 2006
End Date
August 1 2014
Last Update
August 22 2014
Active Locations (2)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
2
Duke University Medical Center
Durham, North Carolina, United States, 27710