Trial of Decitabine in Patients With Acute Myeloid Leukemia

Study Overview
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Brief Summary
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The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.

Official Title
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Randomized Phase 3 Trial of Decitabine Versus Patient's Choice With Physician's Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Cytarabine or Supportive Care
* Drug: Dacogen (decitabine) only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have diagnosed acute myeloid leukemia. Must have a life expectancy of at least 12 weeks. Must sign informed consent. Exclusion Criteria: Must not have acute promyelocytic leukemia (M3 classification) Must not have any other active systemic malignancies. Must not have inaspirable bone marrow. Must not have received previous chemotherapy (except hydroxyurea) for any myeloid disorder. Must not have chronic respiratory disease that requires continuous oxygen use. Must not have received any experimental drug within 4 weeks before randomization. Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization. Must not have known HIV.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Subject's choice of treatment with physician's advice. Subjects preselected their preference of supportive care (including IV fluids, nutrition, and antibiotics) or cytarabine. (These represent one intervention.) | Drug: Cytarabine or Supportive Care<br>* Patient's choice with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 subcutaneously once daily for the first 10 consecutive days of each 28 day cycle, until progression or unacceptable toxicity develops. (These represent one intervention.)<br>|
| Active Comparator: B<br> | Drug: Dacogen (decitabine) only<br>* 20mg/m^2, 1 hour intravenous (IV) for 5 consecutive days of each 28 day cycle. Cycles continue until disease progression or unacceptable toxicity develops.<br>* Other names: decitabine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML. | The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first. | The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp) | Morphologic CR plus CRp rate where Morphologic leukemia-free state defined as less that (<) 5 percent (%) blasts in an aspirate sample with marrow spicules and a count of greater than or equal to (>=) 200 nucleated cells (there should have been no blasts with Auer rods or persistence of extramedullary disease) plus absolute neutrophil count (ANC) greater than (>)1,000 per microliter (/mcL), platelet count of >=100,000/mcL, and the participant must have been independent of transfusions for at least 1 week before each assessment. There was no duration requirement for confirmation of this designation and Morphologic CR without the requirement of platelet count >=100,000/mcL. | Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloid Leukemia, Dacogen, Decitabine, Poor or intermediate-risk cytogenetics