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.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 480

Inclusion Criteria

Patients may be included in the study only if they meet all of the following criteria:

1. Must sign an institutional review board/ethics committee-approved informed consent.

2. Must have a newly diagnosed, histologically confirmed de novo or secondary AML using the World Health Organization classification (e.g., =20% blasts).

3. Must be at least 65 years of age and have either poor- or intermediate-risk cytogenetics as categorized by Southwest Oncology Group.

4. Must have a performance status of 0-2 on the Eastern Cooperative Oncology Group scale (see protocol appendix 1)

5. Must have adequate organ function, defined as:
- Hematology: WBC = 40,000/mm;
- Hepatic: Bilirubin less than or equal to 1.5 times the upper limit of normal,
AST or ALT less than or equal 2.5 times the upper limit of normal; and
- Renal: Creatinine clearance (calculated by the Cockroft and Gault method) greater than or equal to 40 mL/min;

6. Must have a life expectancy of at least 12 weeks.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Must not have acute promyelocytic leukemia (M3 classification).

2. Must not have t(8;21), inv(16) or t(15;17) karyotype abnormalities.

3. Must not have known CNS leukemia.

4. Must not have any other active systemic malignancies.

5. Must not have unstable angina or New York Heart Association (NYHA) class 3 or 4 congestive heart failure (see protocol appendix 3).

6. Must not have inaspirable bone marrow.

7. Must not have received previous chemotherapy (except hydroxyurea), including azacytidine (Vidaza), cytarabine or decitabine, for any myeloid disorder.

8. Must not have chronic respiratory disease that requires continuous oxygen use.

9. Must not have received any experimental drug within 4 weeks of randomization.

10. Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization.

11. Must not have any concomitant medical or psychiatric disorders incompatible with the study (at the discretion of the investigator).

12. Must not have any comorbidity that causes organ dysfunction that is not related to leukemia.

13. Must not have an uncontrolled active infection(s) requiring IV antibiotics.

14. Must not have known HIV.

15. Must not have had radiotherapy for extramedullary disease within 2 weeks prior to study randomization.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials