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A Multicenter, Phase 2 Study of Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia in Complete Remission After Induction Chemotherapy


Phase 2
60 Years
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

A Multicenter, Phase 2 Study of Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia in Complete Remission After Induction Chemotherapy


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of Disease Free Survival at One Year

Outcome Description:

The primary efficacy variable will be 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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Jeffrey E. Lancet, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC-14496

NCT ID:

NCT00387647

Start Date:

August 2006

Completion Date:

October 2013

Related Keywords:

  • Leukemia
  • myeloid
  • acute
  • monocytic
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Duke University Medical CenterDurham, North Carolina  27710