Study Impact on Outcome of Eltrombopag in Elderly Patients With Acute Myeloid Leukemia Receiving Induction Chemotherapy

• Status: Active, not recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French Innovative Leukemia Organisation
• Collaborator: Novartis Pharmaceuticals

Criteria

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.