Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented/confirmed first/second refractory/relapsed AML using World Health Organization classification, except acute promyelocytic leukemia
No more than 2 prior induction regimens (excluding prior HSCT) in their first line treatment and one must have included cytarabine with an anthracycline (or anthracenedione)
Eastern Cooperative Oncology Group performance status of 0 to 2
Adequate hepatic and renal function
White blood cell (WBC) count at randomization less than or equal to (\</=) 50000 cells per cubic millimeter (/mm\^3)
You may not be if
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
Clareo Health | A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
