acute myeloid leukemia AML MedDRA version: 20.0 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Revolade
Product Name: Eltrombopag
Product Code: SB-497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: SB-497115
Sponsors
Technische Universität Dresden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Newly diagnosed AML (including therapy-related or after antecedent MDS) other than APL according to WHO criteria, i.e. bone marrow aspirate or biopsy must contain =20% blasts of all nucleated cells or differential blood count must contain =20% blasts. In AML defined by cytogenetic aberrations according to WHO the proportion of blasts may be =65 years) yes F.1.3.1 Number of subjects for this age range 238
Exclusion criteria
Exclusion criteria: • Acute promyelocytic leukemia (APL) • History of MDS or AML treatment with TPO-R agonists (Revolade, NPlate or other TPO-R agonists), hypomethylating agents or intensive chemotherapy • NYHA stage = 2 due to heart insufficiency • Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results • Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication • Active and uncontrolled infections • positive Human Immunodeficiency Virus (HIV) or positive Hepatitis B or C serology • Patients unable to swallow medication • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to eltrombopag or DAC or excipients that contraindicate their participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study whether supportive treatment with eltrombopag improves treatment change-free survival (TCFS) in AML patients =65 years of age when added to standard treatment with DAC ;Secondary Objective: • overall survival (OS) • relapse free survival (RFS) • overall response rate (CR, PR, SD) • number of bone marrow blasts after 5, 9 and 12 months • quality of life (QLQ-C30 and SF-36) • bleeding events • median platelet counts • number of platelet transfusions • hospitalization rate • safety and tolerability of treatment with EPAG / placebo • impact of comorbidities on predicting overall survival;Primary end point(s): Treatment change-free survival (TCFS) ;Timepoint(s) of evaluation of this end point: date of treatment change or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: • whole study • date of relapse, death • cycles 1-4, 5, 9 and 12 • follow up after treatment discontinuation: week 2, month 3, 6, 9, 12, 24, 36, and 48 ;Secondary end point(s): • Overall Survival (OS) in presence of competing risk treatment change • Overall response rate (CR, PR, SD) • Relapse free survival (RFS) • Median platelet counts • Number of platelet transfusions during cycles 1-4 • Incidence of bleeding events • Number of bone marrow blasts from baseline and after 5, 9 and 12 months • Hospitalization rate (days in hospital) • Safety and tolerability of treatment with EPAG / placebo • Quality of life • impact of comorbidities on predicting overall survival | — |
Countries
Germany
Contacts
Public Contactcoordinating investigator
Universitätsklinikum Dresden, Med. Klinik und Poliklinik I
Outcome results
None listed