Status:
COMPLETED
Phase II Study of Decitabine and Cytarabine for Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Lead Sponsor:
Annie Im, M.D.
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
Primary objective: To determine the efficacy of an induction regimen using decitabine as an epigenetic primer followed by cytarabine in the treatment of older patients with newly diagnosed Acute myelo...
Eligibility Criteria
Inclusion
- 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.
- Eastern Cooperative Oncology Group Performance Status of 0-2
- Cardiac ejection fraction ≥45%
- 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
- Patients with acute promyelocytic leukemia
- Life expectancy ≤3 months
- Prior use of any hypomethylating agent or cytarabine
- Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
- Serum creatinine \> 2x upper limit of normal
- Aspartate aminotransferase (AST),alanine aminotransferase (ALT), or total bilirubin \> 5x upper limit of normal
- History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent
- Patient may not be receiving any other antineoplastic agents (hydroxyurea is allowed)
- 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.
- Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, or cardiac disease).
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2017
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01829503
Start Date
February 1 2013
End Date
November 30 2017
Last Update
November 14 2019
Active Locations (1)
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1
University of PIttsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232