Acute Myeloid Leukaemia (AML) in elderly population (equal or older than 60 years). MedDRA version: 17.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.0 Level: HLT Classification code 10024291 Term: Leukaemias acute myeloid System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 17.0 Level: SOC Classification code 10029104 Ter
Conditions
Sponsors
European Orgainzation for the Research and Treatment of Cancer (EORTC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?Age = 60 years ? WHO Performance status: = 2 ? Eligible for standard intensive chemotherapy ?Patients of reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 3 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly ? Have newly diagnosed AML that is cytopathologically confirmed according to WHO classification (Patients can be diagnosed with AML two months prior to randomization) ?De novo or secondary AML is allowed WBC is =30x109/L (measured within 72 hours prior to randomization) ? The following laboratory assessments should be done within 7 days prior to randomization and should be within the following range: ? SGOT (AST) and SGPT (ALT) =65 years) yes F.1.3.1 Number of subjects for this age range 386
Exclusion criteria
Exclusion criteria: ? Presence of acute promyelocytic leukaemia (APL, i.e. AML-M3 with t(15;17)(q22;q12); PML-RARA fusion gene and cytogenetic variants) ? Presence of blast crisis of chronic myeloid leukaemia ? Presence of active central nervous system (CNS) leukaemia ? No prior treatment for AML (relapsed AML is not allowed), these are any antileukaemic therapy including investigational agents and hypomethylating agents (decitabine, 5-azacytidine). Exception: Treatment with Hydroxyurea (HU) is allowed to control the leukocytosis if given for a maximum of 5 days and is stopped at least two days prior to the start of any of the protocol regimens ? No prior treatment for MDS or MPN with: -hypomethylating agents (decitabine, 5-azacytidine), OR -intensive chemotherapy or transplantation within the last three years ? Presence of concomitant severe cardiovascular disease which would make intensive chemotherapy impossible, i.e. arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease, reduced left ventricular function assessed by MUGA scan or echocardiogram. ? Presence of concomitant malignancy requiring chemotherapy or any malignancy (except basal and squamous cell carcinoma of the skin) for which the patient received chemotherapy within 6 months prior to randomization ? Presence of active uncontrolled infection ? Presence of any psychological, familial, sociological or geographical condition in the opinion of the investigator potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess, the effect of 10-day decitabine at a dose of 20 mg/m2 versus conventional induction chemotherapy (“3+7”) on overall survival (OS) in older AML patients.;Secondary Objective: Between two treatment arms: ? To compare efficacy : complete response rate, response rate and disease-free survival (DFS) and progression-free survival (PFS) ? To compare safety and toxicity profile ? To determine feasibility of allogeneic hematopoietic cell transplantation with reduced intensity conditioning ? To determine transplant outcome in terms of disease free survival, incidence of non-relapse related mortality (NRM) and incidence of relapse ? To determine health/economic impact by of days staying in hospital and transfusion needs for selected sites ? To compare Quality of Life (QoL) of patients ? To determine impact of baseline physical and functional conditions ? To identify, by translational research, potential biomarkers which are of prognostic importance; in addition, in decitabine arm, identification of DNA methylation signature of response will be assessed ? To determine prognostic value of minimal residual disease (MRD) regarding risk of relapse ;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Time from randomization until death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? CR/CRi rate, response rate (CR/CRi and PR), overall CR/CRi rate, DFS, PFS ? Safety and toxicity ? Transplantation feasibility: percentage of patients transplanted ? Outcome post-transplantation: PFS, incidence of relapse or progression, and incidence of NRPM (or TRM) ? Days of staying in hospital and transfusion needs ? HRQoL (EORTC QLQ-C30, ELD14) ? The prognostic value of baseline physical and functional conditions using a comprehensive geriatric assessment tools (short;Timepoint(s) of evaluation of this end point: Progression Free Survival (time from randomization till progression, relapse or death without progression) | — |
Countries
Belgium, Bulgaria, Croatia, Czech Republic, France, Germany, Italy, Lithuania, Netherlands, Portugal, Slovakia
Contacts
Public ContactClinical Operations Department
European Organisaton for the Research and Treatment of Cancer (EORTC)
Outcome results
None listed