MIRROS: This phase III trial evaluating a drug (cytarabine) alone and in combination with a chemotherapy (idasanutlin) for the treatment of Acute Myeloid Leukaemia (AML)A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Study of Idasanutlin, an MDM2 Antagonist, With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Exclusion

• First relapsed participants aged less than (<) 60 years with first CR duration greater than (>) 1 year
• Participants with prior documented antecedent hematological disorder (AHD)
• AML secondary to any prior chemotherapy unrelated to leukemia
• Participants who are either refractory to or relapsed within 90 days of receiving a regimen containing a cumulative dose of greater than or equal to (>/=) 18 g/m^2 of cytarabine
• Participants who have received allogeneic HSCT within 90 days prior to randomization
• Participants who have received immunosuppressive therapy for graft versus host disease or for engraftment syndrome after autologous stem cell transplantation within 2 weeks prior to randomization
• Prior treatment with an Murine Double Minute 2 (MDM2) antagonist
• Participants receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 30 days from first receipt of study drug
• Participants with a history of other malignancy within 5 years prior to screening except for malignancy that has been in remission without treatment for at least 2 years prior to randomization
• Participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
• Participants with extramedullary AML with no evidence of systemic involvement
• Pregnant or breastfeeding participants