Acute myeloid leukemia (AML), de novo, FAB classification other than M3 or WHO classification other than APL t(15,17), > 60 years, abesence of any other antededent hematologic disease of >8 months, ECOG performance status 0, 1 or 2, life expectancy > 3 months, adequate organ functions to receive intensive chemotherapy MedDRA version: 17.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Neulasta
Pharmaceutical Form: Injection
INN or Proposed INN: PEGFILGRASTIM
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Sponsors
Medical University of Vienna, Dep. of Internal Medicine I, division of Hematology & Hemostaseology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients must have a morphologically confirmed diagnosis of AML with FAB classification other than M3 or WHO classification other than APL t(15;17), based on bone marrow aspiration and biopsy. • Patients must have reached their 60th birthday. • ECOG performance status of 0, 1, or 2. • Life expectancy >3 months • Adequate organ function to receive intensive chemotherapy • Written informed consent. 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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: • Patients with APL • Subjects with blast transformation of chronic myeloid leukemia or leukemia developing from myeloproliferative diseases. • Leukemia following a documented myelodysplasic syndrome known for more than 8 months. • Patients with a concurrent malignancy, except stage 1 cervical intraepithelial carcinoma and basal cell carcinoma. • Previous treatment with chemotherapy. • Patients who have known HIV-infection. • Impaired hepatic or renal function i.e.: ALT and/or AST > 2.5 x ULN; bilirubin > 2 x ULN; Serum creatinin > 2 x ULN (after adequate hydration) (unless these are most likely caused by AML organ infiltration) • Severe cardiac disease: Patients must not have a severely reduced left ventricular function (shortening fraction <20% as assessed by 2-D ECHO within 6 months prior initiation of induction therapy), unstable cardiac arrhythmias or unstable angina. • Severe obstructive or restrictive pulmonary disease. • Patients must not have received systemic chemotherapy or more than one dose of intrathecal chemotherapy for acute leukemia. Administration of hydroxyurea or etoposid to control high blast cell counts prior to induction-chemotherapy is permitted. • Psychiatric, addictive, or any disorder, which compromises ability to give truly informed consent for this study. • Concerns for subject’s compliance with the protocol procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Tolerability (number of cycles of consolidation therapy; toxicity) of intensified consolidation therapy in elderly AML patients Adverse event profile ;Secondary Objective: The rate of complete remission (CR) following induction chemotherapy Overall survival, continuous complete remission and disease-free survival Evaluation of prognostic factors: Age, (<75 years, =75years), karyotype, molecular fusion proteins (multiplex-PCR), mutations (KIT, NPM, FLT3), serum tryptase level at diagnosis and at complete hematologic remission, histologic markers (% CD34 positive cells, microvessel density, fibrosis) Quality of life (ECOG, Charlson Score) Percent patients with ANC=500/µL on day 10 Incidence and duration of febrile neutropenia (=days per cycle with ANC <500 cells/µL and temperature =38°C) Days in hospital Comparison between cycle 3 and cycle 4 with regard to the duration of ANC <500 cells/µL and duration of hospitalisation Efficacy and Pharmacokinetic of PEG-Filgrastim in Consolidation therapy ;Primary end point(s): • The number of chemotherapy-cycles patients received (including patients fraction having received all cycles of consolidation chemotherapy) and the drop out rate • Adverse event profile ;Timepoint(s) of evaluation of this end point: All endpoints will be evaluated at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of subjects in CR after induction therapy • For all survival, continuous complete remission and disease free survival • Quality of life (ECOG, Charlson Score) • Identification of prognostic factors including age (<75 years, =75years), karyotype, initial leukocyte count, molecular fusion proteins (multiplex-PCR), mutations (KIT, NPM, FLT3), serum tryptase level at diagnosis and at complete hematologic remission, histologic markers (% CD34 positive cells, microvessel density, fibrosis), flow cytometric parameters (progenitor subsets, MRD) • Relapse rate after intensified chemotherapy • Percent patients with ANC =500/µL on day 10 • Incidence and duration of febrile neutropenia (=days/cycle; ANC <500 cells/µL, temperature =38°C) • Days in hospital • Comparison between cycle 3 and 4 with regard to the duration of ANC <500 cells/µL and duration of hospitalisation • Pharmacokinetics of Peg-Filgrastim;Timepoint(s) of evaluation of this end point: All endpoints will be evaluated at the end of the study. | — |
Countries
Austria
Outcome results
None listed