Double-Blind Placebo-Controlled Randomized Phase 2 Study evaluating the efficacy of lirilumab (IPH2102/BMS-986015) as Maintenance Treatment administered in elderly patients with Acute Myeloid Leukemia (AML) in first complete remission
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
152
every 3 months
every 4 weeks
every 4 weeks
Leukemia-Free Survival
Time frame: from date of randomization until the date of first documented relapse, assessed up to 48 months
Number of Participants With Adverse Events
Number of Participants with Adverse Events based on full physical examination each treatment visit and collection of AEs
Time frame: from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit, up to 24 months
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CHU d'Amiens
Amiens, France
CHU Angers
Angers, France
Centre hospitalier Victor Dupouy
Argenteuil, France
Centre hospitalier de la côte Basque
Bayonne, France
CHU de Besançon
Besançon, France
CHG de Béziers
Béziers, France
CH de Blois
Blois, France
Hôpital Avicenne
Bobigny, France
Hôpital Morvan CHU Brest
Brest, France
CH René Dubos
Cergy-Pontoise, France
...and 33 more locations