PATIENT WHIT LMA MedDRA version: 8.1 Level: HLT Classification code 10024291 Term: Leukaemias acute myeloid
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Etoposide
CAS Number: 33419-42-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100
Sponsors
AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO A.O. DI RILIEVO NAZIONALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: FOR R1 1. A diagnosis of untreated AML or high-risk MDS is required. 2. The diagnosis must be one of o de novo AML and variants thereof including rare diagnostic subsets , o secondary AML, o MDS-related AML or high-risk MDS RAEB-2 by WHO criteria , o primary myeloid sarcoma MS 3. Age 16 years. 4. ECOG performance status 0-2, unless a performance of 3 is unequivocally caused by the disease itself and not by preexisting comorbidity, and is considered and/or documented to be reversible following the application of antileukemic therapy and appropriate supportive measures. 5. Informed consent signed by the patient or by a parent/tutor in patients aged 18 years. FOR R2 1. Confirmed CR status after Random 1 check of BM and PB morphology 2. Sufficient amount of autologous blood stem cells 2 x106/kg following A8 consolidation/mobilization chemotherapy cycle no. 3 3. Age 65 years 4. Signed informed consent by the patient or by parent/tutor in patients aged 18 years 5. SR risk class or HR risk class if ineligible to or unable to proceed to allogeneic SCT 6. Functional echocardiography of the left ventricle with ejection fraction 50 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: FOR R1 1. Diagnosis of acute promyelocytic leukemia. 2. Pre-existing, uncontrolled pathology such as heart failure congestive/ischaemic, acute myocardial infarction within the past 3 months, untreatable arrythmias, NYHA classes III and IV , severe liver disease with serum bilirubin 3 mg/dL and/or ALT 3 x upper normal limit unless attributable to AML , kidney function impairment with serum creatinine 2 mg/dL unless attributable to AML , and severe neuropsychiatric disorder that impairs the patient s ability to understand and sign the informed consent, or to cope with the intended treatment plan. 3. Pre-existing HIV positive serology i.e. already known before enrolmentA history of cancer that is not in a remission phase following surgery and/or radiotherapy and/or chemotherapy, with life expectancy 1 year. 4. Pregnancy FOR R2 1. Unresolved hematological or extrahematological toxicity of CTC-NCI Common Toxicity Criteria from the National Cancer Institute grade II or greater 2. Unresolved/unimproved bacterial or fungal infections from prior therapy, involving major anatomical sites central nervous system, respiratory tract, gastrointestinal system, genito-urinary system, soft tissues and muscolo-skeletal structures and requiring patient hospitalization with use of parenteral antimicrobial and antifungal drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Remission induction R1 Primary endpoint Complete remission CR rate after cycle 1 Remission consolidation R2 Primary endpoint Length of remission DFS, disease-free survival ;Secondary Objective: Remission induction R1 Secondary efficacy outcome measures 1. CR with incomplete hematology recovery CRi 2. Complete cytogenetic remission CRc 3. Treatment-related death TRD 4. Feasibility and efficacy of treatments in different age and risk groups Safety outcome measures Toxicity clinical adverse events Remission consolidation R2 Secondary efficacy outcome measures 1. Overall survival OS 2. Remission duration and cumulative incidence of relapse CIR 3. Treatment-related death TRD 4. Feasibility and efficacy of treatments in different age and risk groups 5. Significance and clinical correlates of remission monitoring results 6. Quality of Life evaluation in long term survivors Safety outcome measures Toxicity clinical adverse events Outcome study Descriptive analyses of the patients not included in R1 and R2. Prospective analysis of risk-oriented allogeneic stem cell transplantation strategies. For patients in Random 1, explorative ana;Primary end point(s): FOR R1 Remission induction R1 Primary endpoint FOR R2 Primary endpoint Length of remission DFS, disease-free survival | — |
Countries
Italy
Outcome results
None listed