Azacitidine as Maintenance Therapy in Treating Older Patients With Acute Myeloid Leukemia in Complete Remission After Chemotherapy

Conditions:Blood Cancer, Hematology, Leukemia
Therapuetic Areas:Hematology, Oncology
Age Range:Any
Start Date:August 2006

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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

RATIONALE: Azacitidine may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Giving azacitidine as maintenance therapy may keep cancer from
coming back.

PURPOSE: This randomized phase II trial is studying how well azacitidine works when given as
maintenance therapy in treating older patients with acute myeloid leukemia in complete
remission after chemotherapy.



- Determine the disease-free survival of older patients with acute myeloid leukemia (AML)
in first complete remission treated with low-dose azacitidine as post-remission


- Determine overall survival of these patients receiving azacitidine as maintenance

- Determine the safety and tolerability of azacitidine as maintenance therapy in these

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1
of 3 treatment arms.

- Arm I: Patients receive azacitidine subcutaneously (SC) once daily on days 1-5 and

- Arm II: Patients receive azacitidine SC once daily on days 1-5 and 8-9.

- Arm III: Patients receive azacitidine SC once daily on days 1-5. In all arms, treatment
repeats every 4 weeks for up to 12 courses in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 1 year.

PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.


- Histologically or cytologically confirmed acute myeloid leukemia (AML) with > 20%
blasts in bone marrow

- No promyelocytic leukemia with cytogenetics showing the (15;17) translocation

- No leukemia secondary to chemotherapy

- Achieved first complete remission after completion of a standard induction
chemotherapy regimen

- Received no more than 2 induction chemotherapy courses

- Confirmation of complete remission is defined as all of the following:

- Less than 5% blasts in the bone marrow specimen with > 10% cellularity and
absence of Auer rods

- Peripheral blood neutrophil count > 1,500/mm³

- Platelet count > 100,000/mm³

- Received no more than 2 courses of any consolidation chemotherapy

- No prior relapse after complete remission for AML

- No metastatic disease

- No hepatic tumors

- No known leukemic involvement of the CNS


- ECOG performance status 0-2

- Life expectancy ≥ 2 months

- Absolute neutrophil count > 1,500/mm³

- Platelet count > 100,000/mm³

- Fertile patients must use effective contraception

- No active malignancy other than AML

- Bilirubin < 1.5 times upper limit of normal (ULN)

- AST and ALT < 2.5 times ULN

- Creatinine < 1.5 times ULN OR creatinine clearance > 60 mL/min

- No known or suspected hypersensitivity to azacitidine or mannitol

- No uncontrolled intercurrent illness including, but not limited to, any of the

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situations that would limit compliance with study

- No active HIV or hepatitis B or C infection


- See Disease Characteristics

- Recovered from prior therapy

- No radiation therapy, chemotherapy, or cytotoxic therapy for treatment of conditions
other than AML within the past 4 weeks

- No other investigational drugs within the past 30 days

- No prior azacitidine or decitabine

- No other concurrent cytotoxic or investigational drugs
We found this trial at
4117 East Fowler Avenue
Tampa, Florida 33612
(813) 745-4673
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Moffitt Cancer...
Tampa, FL
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