Active, not recruiting
Phase 2
Study Impact on Outcome of Eltrombopag in Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy
Condition(s) studied
Acute Myeloid Leukemia
Investigational drug(s) / intervention(s)
Eltrombopag: Eltrombopag concomitant with induction chemotherapy in patient with AML
Placebo: Placebo concomitant with induction chemotherapy patients with AML
Study summary
Phase II randomized placebo-controlled study to assess the impact on outcome of Eltrombopag administered to elderly patients with Acute Myeloid Leukemia (AML) receiving induction chemotherapy. A phase II multicenter and randomized placebo-controlled study
Eligibility
Inclusion Criteria
* 60 years of age.
* AML de novo, except AML 3 and AML 7.
* AML with no adverse cytogenetic according to Medical Research Council (MRC) 2010 classification.
* Subjects should be eligible for intensive chemotherapy by Daunorubicine, cytarabine, Lomustine.
* Eastern Cooperative Oncology Group (ECOG) \< 3 (appendix 1).
* SORROR ≤ 3 (appendix 2).
* Adequate baseline organ function defined by the criteria below:
* Total bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) range except cases clearly not indicative of inadequate liver function
* Alanine Aminotransferase (ALAT) and Aspartate Aminotransferase (ASAT) ≤ 3 x ULN
* Creatinin ≤ 1.5 x ULN
* Adequate cardiac function with Left Ventricular Ejection fraction (LVEF) ≥50%
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
* Women will be menopausal to be enrolled
* The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient and before the start of induction chemotherapy.
* Affiliated to the French Social Security (Health Insurance).
Exclusion criteria
* Subjects with a diagnosis of acute promyelocytic (M3) or megakaryocytic leukemia (M7).
* AML with adverse cytogenetic according to the MRC 2010 classification.
* AML secondary to Myelodysplastic syndrome (MDS), Myeloproliferative neoplasm (MPN)
* Clinical symptoms suggesting active central nervous system leukemia, or presence of extramedullary AML.
* Previous exposure to anthracycline.
* Previous AML treatment other than hydroxyurea.
* Treatment with an investigational drug within 30 days or 5 half-life whichever is longer, preceding the first dose of study medication.
* History of thromboembolic event or other condition requiring ongoing use of anticoagulation either with warfarin or low molecular-weight heparin.
* History of another malignancy within the past three years except basal cell carcinoma of the skin or carcinoma in situ of the cervix.
* 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).
* Patient requiring platelets transfusion with platelets \> 10 x 10 Giga/L, for whatever reason.
* History of treatment with romiplostim or other Thrombopoietin receptor (TPO-R) agonists.
* Uncontrolled active infection.
* 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.
* Known active HIV, Hepatitis B or C infection.
* Pregnancy or breastfeeding.
Primary outcome measure(s)
- Overal survival rate — 12 months after beginning treatment
overall survival rate at month 12 (year 1) between the two arms, with or without 200 mg of Eltrombopag daily after induction chemotherapy.
Trial sites (15)
| Facility | City | Region | Status |
| CHU ANGERS - Maladies du sang |
Angers |
France |
|
| CH de la Côte Basque - Hématologie |
Bayonne |
France |
|
| CHU Estaing |
Clermont-Ferrand |
France |
|
| CHU Grenoble - Hématologie Clinique |
Grenoble |
France |
|
| Institut Paoli-Calmettes - Hématologie 2 |
Marseille |
France |
|
| Hôpital Saint-Eloi - Hématologie Clinique |
Montpellier |
France |
|
| HOPITAL E. MULLER - Hématologie |
Mulhouse |
France |
|
| CHU HOTEL DIEU - Hématologie Clinique |
Nantes |
France |
|
| CHU Caremeau |
Nîmes |
France |
|
| CHU La Milétrie - Hématologie Clinique |
Poitiers |
France |
|
| CHU Pontchaillou |
Rennes |
France |
|
| CHU Hautepierre - Hématologie |
Strasbourg |
France |
|
| Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie |
Toulouse |
France |
|
| Sponsor FILO |
Tours |
France |
|
| CHU de Brabois |
Vandœuvre-lès-Nancy |
France |
|
More French Innovative Leukemia Organisation trials in France
Other trials for the same condition