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Phase II Study of Decitabine and Cytarabine for Older Patients With Newly Diagnosed AML

Phase 2
60 Years
Open (Enrolling)
Acute Myeloid Leukemia

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Trial Information

Phase II Study of Decitabine and Cytarabine for Older Patients With Newly Diagnosed AML

Inclusion Criteria:

1. Age ≥ 70, or age ≥ 60 ineligible for treatment with standard induction chemotherapy
(based on physician discretion or patient refusal), with a new diagnosis of AML
based on World Health Organization Classification.

2. Eastern Cooperative Oncology Group Performance Status of 0-2

3. Cardiac ejection fraction ≥45%

4. Males are eligible to enter and participate in the study if they have either had a
prior vasectomy or agree to avoid sexual activity or use adequate contraception from
screening through two months post the last dose of decitabine

Exclusion Criteria:

1. Patients with acute promyelocytic leukemia

2. Life expectancy ≤3 months

3. Prior use of any hypomethylating agent or cytarabine

4. Uncontrolled, life-threatening infection that is not responding to antimicrobial

5. Serum creatinine > 2x upper limit of normal

6. Aspartate aminotransferase (AST),alanine aminotransferase (ALT), or total bilirubin >
5x upper limit of normal

7. History of psychiatric disorder which may compromise compliance with the protocol or
which does not allow for appropriate informed consent

8. Patient may not be receiving any other antineoplastic agents (hydroxyurea is allowed)

9. Concurrent malignancy. Exception: Subjects who have been disease-free for 5 years, or
subjects with a history of completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma are eligible. Subjects with second
malignancies that are indolent or definitively treated may be enrolled.

10. Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated
respiratory, hepatic, renal, or cardiac disease).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete Remission Rate

Outcome Description:

The Complete Remission Rate for 39 evaluable patients will be reported for the following treatment: decitabine and cytarabine for older patients with newly diagnosed AML. The proportion of patients experiencing per-protocol CR will be calculated with a 90% exact (Clopper-Pearson) confidence interval.

Outcome Time Frame:

3 years

Safety Issue:



United States: Data and Safety Monitoring Board

Study ID:




Start Date:

February 2013

Completion Date:

February 2016

Related Keywords:

  • Acute Myeloid Leukemia
  • Phase II
  • decitabine
  • cytarabine
  • older patients
  • newly diagnosed
  • AML
  • Newly Diagnosed AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213