Study Impact on Outcome of Eltrombopag in Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Drug: Placebo
- Registration Number
- NCT03603795
- Lead Sponsor
- French Innovative Leukemia Organisation
- Brief 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
- Detailed Description
Subjects will be randomized 1:1 to receive Eltrombopag or matching placebo, in double blinded.
To compare overall survival rate at 12 months between the two arms, with or without 200 mg of Eltrombopag daily after induction chemotherapy
Arm A : Eltrombopag 200 mg (100 mg/day for east Asian heritage) once daily from day 11 of induction chemotherapy to AML response evaluation or platelets count \> 100 x 10 Giga/L (maximum day 45)
Arm B : Placebo once daily from day 11 of induction chemotherapy to AML response evaluation or platelets count \> 100 x 10 Giga/L. (maximum day 45)
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 110
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Placebo 55 patients will be randomized in the comparator arm B and will received: Placebo once daily from day 11 of induction chemotherapy to AML response evaluation or platelets count \> 100 x 10 Giga/L (maximum day 45) Placebo 200mg = 4 Tablets of 50 mg will be done more than 2 hours before Daunorubicin and cytarabine administrations, to avoid vomiting secondary to anthracycline administration. Chemotherapy administration would be performed among standard practice: * Daunorubicin: 60 mg/m² D1 to D3 * Cytarabine: 100 mg/m²/day, in a continuous 24h-IV infusion D1 to D7 * Lomustine (CCNU): 200 mg/m² per os, at D1. A Eltrombopag 55 patients will be randomized in the experimental arm A. If platelets counts \< 100 x 10 Giga/L, patients will be treated with Eltrombopag 200 mg/day per os from day 11 of induction chemotherapy to platelets counts \> 100 x 10 Giga/L or maximum to day 45. If platelets counts ≥ 100 x 10 Giga/L on day 11, the start of IP will be delayed until platelets \< 100 x 10 Giga/L. Chemotherapy administration would be performed among standard practice: * Daunorubicin: 60 mg/m² D1 to D3 * Cytarabine: 100 mg/m²/day, in a continuous 24h-IV infusion D1 to D7 * Lomustine (CCNU): 200 mg/m² per os, at D1. 200mg = 4 Tablets of 50 mg will be done more than 2 hours before Daunorubicin and cytarabine administrations, to avoid vomiting secondary to anthracycline administration. Investigational Product (IP) will be taken at the same time daily on an empty stomach 1 hour before or 2 hours after a meal or preferably no calcium or dairy products.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Leukemia Free Survival at month 12 (one year) 12 months after beginning treatment relapse measurement before month 12
Long-term survival 2, 3 and 5 years after first treatment administration Overall survival at 2, 3 and 5 years
Response rate (CR and CRi) at day 45 At day 45 Time to platelet transfusion independence platelets count daily from baseline to the end of induction (day 45) and then at day 60, day 90, monthly until year 1 and finally at year 2, year 3 and year 5 More than 3 days with platelets count ≥ 10 Giga/L
Percentage of patients with platelets count > 100 Giga/L at day 45 At day 45 platelets count \>100 Giga/L
Trial Locations
- Locations (15)
Hôpital Saint-Eloi - Hématologie Clinique
🇫🇷Montpellier, France
HOPITAL E. MULLER - Hématologie
🇫🇷Mulhouse, France
CH de la Côte Basque - Hématologie
🇫🇷Bayonne, France
CHU ANGERS - Maladies du sang
🇫🇷Angers, France
CHU Estaing
🇫🇷Clermont-Ferrand, France
Institut Paoli-Calmettes - Hématologie 2
🇫🇷Marseille, France
CHU Grenoble - Hématologie Clinique
🇫🇷Grenoble, France
CHU HOTEL DIEU - Hématologie Clinique
🇫🇷Nantes, France
CHU Caremeau
🇫🇷Nîmes, France
CHU La Milétrie - Hématologie Clinique
🇫🇷Poitiers, France
CHU Pontchaillou
🇫🇷Rennes, France
Sponsor FILO
🇫🇷Tours, France
CHU Hautepierre - Hématologie
🇫🇷Strasbourg, France
Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie
🇫🇷Toulouse, France
CHU de Brabois
🇫🇷Vandœuvre-lès-Nancy, France