A trial to compare the ability of the oral medication sapacitabine plus injectable decitabine with that of the standard treatment of injectable decitabine only in controlling newly diagnosed acute leukemia in the elderly population not suitable for receiving intensive therapy according to doctor`s assessment or not willing to receive intensive therapy despite doctor`s recommendation.

Phase 1

Conditions: Acute myeloid leukemia (AML) is a cancer of the myeloid line of blood cells, characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells.
MedDRA version: 16.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2013-003586-34-IE

Lead Sponsor: Cyclacel Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 505

Inclusion Criteria

•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)
•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
•Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•Creatinine <1.5 x institutional upper limit of normal (ULN)
•Total bilirubin or direct bilirubin < 1.5 x ULN
•Alanine aminotransferase (ALT or SGPT)< 2 x ULN
•Life expectancy reasonably adequate for evaluating the treatment effect
•Patient must be able to swallow capsules
•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
•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
•Ability to understand and willingness to sign the informed consent form

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 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 505

Exclusion Criteria

•AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
•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
•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
•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
•Known hypersensitivity to decitabine
•Known to be HIV-positive

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to compare the overall survival between Arm A and Arm C.;Secondary Objective: The secondary objectives are 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. ;Primary end point(s): The primary efficacy endpoint is overall survival. ;Timepoint(s) of evaluation of this end point: Final analysis will occur at approximately 424 deaths.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary efficacy endpoints are the response rate of CR, CRp, PR, HI, SD and their corresponding durations, transfusion requirements, number of hospitalized days, and 1-year survival. ;Timepoint(s) of evaluation of this end point: Final analysis will occur at approximately 424 deaths.