elderly patients > 60 years, with acute myeloid leukemia
Conditions
Interventions
Product Name: Eltrombopag
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: eltrombopag
Concentration unit: mg milligram(s)
Concent
Sponsors
GOELAMS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 60 years of age. 2. AML de novo according to the WHO 2008 classification. 3. Subjects should be eligible for chemotherapy 4. ECOG =65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: 1. Subjects with a diagnosis of acute promyelocytic (M3) or megakaryocytic leukemia (M7). 2. AML with adverse cytogenetic according to the MRC 2010 classification. 3. AML secondary to MDS or MPN 4. Previous exposure to anthracycline. 5. Previous AML treatment other than hydroxyurea. 6. Any serious medical condition, laboratory abnormality, or psychiatric illness that would place the participant at an unacceptable risk or prevent them from giving informed consent. 7. History of thromboembolic event or other condition requiring ongoing use of anticoagulation either with warfarin or low molecular-weight heparin. 8. History of another malignancy within the past three years except basal cell carcinoma of the skin or carcinoma in situ of the cervix. 9. Pre-existing cardiovascular disease (including congestive heart failure, New York Heart Association [NYHA] Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation), or subjects with a QTc >450 msec (QTc >480 msec for subjects with Bundle Branch Block). 10. Patient requiring platelets transfusion with platelets > 10 x 109/L, for whatever reason. 11. History of treatment with romiplostim or other TPO-R agonists 12. Uncontrolled active infection. 13. Clinical symptoms suggesting active central nervous system leukemia. 14. Known active HIV, Hepatitis B or C infection 15. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare overall survival rate at 12 months between the two arms, with or without 200 mg of Eltrombopag daily after induction chemotherapy.;Secondary Objective: - Response rate (CR and CRi) at day 45 - Leukemia Free Survival at 12 months - Overall survival at 2, 3 and 5 years. - Percentage of patients with platelets count > 100 G/L at day 45 - Time to platelet transfusion independence (more than 3 days with platelets = 10 G/L) - Number of accident haemorrhage event = grade 3 until day 45 - Number of days with platelets 100 G//L - Time to PMN counts > 0.5 G/L - Time to haemoglobin counts > 8 g/dl - Time to red blood cells transfusion independence - Safety assessment of eltrombopag utilizing NCI-CTC criteria v4. - Evaluation of Quality of Life;Primary end point(s): A 15% increase in the overall survival rate at 12 months with 200 mg of Eltrombopag daily;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A. Response rate (CR and CRi) at day 45 B. Leukemia Free Survival at 12 months C. Overall survival at 2, 3 and 5 years. D. Percentage of patients with platelets count > 100 x 109/L at day 45 E. Time to platelet transfusion independence (more than 3 days with platelets = 10 x 109/L) F. Number of accident haemorrhage event = grade 3 until day 45 G. Number of days with platelets 100 x 109/L J. Time to PMN counts > 0.5 x 109/L K. Time to haemoglobin counts > 8 g/dl L. Time to red blood cells transfusion independence M. Safety assessment of eltrombopag utilizing NCI-CTC criteria v4. N. Evaluation of Quality of Life ;Timepoint(s) of evaluation of this end point: survival at 5 years | — |
Countries
France
Contacts
Public ContactMINEUR Ariane
GOELAMS
Outcome results
None listed