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Title A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients with Newly Diagnosed Acute Myeloid Leukemia

IRB CYC 1911

CC CC12-206

Hospital Florida Weston, Main Campus

Stage N/A

Phase Phase 3

Disease Leukemia, Acute Myeloid (AML)

Drug Sapacitabine

Description

Description

  1. Primary
    • The primary objective is to compare the overall survival between Arm A and Arm C if Arm A is tolerable.
  2. Secondary
    • To assess the response rate of CR, CRp, PR, HI, SD and their corresponding durations, transfusion requirements, number of hospitalized days, 1 year survival and safety.
Inclusion Criteria

Inclusion Criteria

Patients must fulfill all of the following criteria:
  1. A histologically or pathologically confirmed diagnosis of AML based on WHO classification which has not been treated by any systemic therapy administered orally,intravenously or subcutaneously (except hydroxyurea)
  2. Age ≥ 70 years for whom the treatment of choice is low-intensity therapy by investigator assessment or who are not willing to receive intensive induction therapy recommended by investigator
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (See Appendix B)
  4. Adequate renal function
    • Creatinine < 1.5 x institutional upper limit of normal (ULN)
  5. Adequate liver function
    • Total bilirubin or direct bilirubin < 1.5 x ULN
    • Alanine aminotransferase (ALT or SGPT) < 2 x ULN
  6. Life expectancy reasonably adequate for evaluating the treatment effect
  7. Patient must be able to swallow capsules
  8. Patients must be at least 2 weeks from major surgery, radiation therapy, participation in other investigational trials and have recovered from clinically significant toxicities of these prior treatments
  9. All men of reproductive potential must agree to practice effective contraception for 4 weeks prior to study entry, during the entire study period and for 2 months after the study unless documentation of infertility exists.
  10. Ability to understand and willingness to sign the informed consent form
Exclusion Criteria

Exclusion Criteria

Patients are to be excluded from the study if they meet any of the following criteria:
  1. AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
  2. Having received hypomethylating agents or other anti-cancer agents administered orally, intravenously or subcutaneously for MDS or MPD that preceded the AML;hydroxyurea used to control peripheral white blood cells count (WBC) or thrombocytosis and lenalidomide used to treat transfusion-dependent anemia are not considered anti-cancer therapy
  3. Patients with suspected or known central nervous system (CNS) involvement by leukemia should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  4. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active cancer(s) other than AML, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients receiving intravenous antibiotics for infections that are under control may be included in this study. Active cancer other than AML refers to cancer that requires systemic chemotherapy or biological therapy within 6 months of the study entry. Patients who have received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 6 months may participate in this study.
  5. Known hypersensitivity to decitabine
  6. Known to be HIV-positive