Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Annie Im, M.D.
Age
60–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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 therapy
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).
Clareo Health | Phase II Study of Decitabine and Cytarabine for Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
