Health Condition 1: null- Acute Myeloid Luekemia
Conditions
Interventions
Intervention1: Volasertib plus Low Dose Cytarabine: 350mg, Single dose
Day 1 and 15 of each 28-day cycle
intravenous infusion (1 hour)plus 2 x 20 mg (total 40 mg/day) Days 1 to 10 in 28-day cycles
subcutaneous injection.
Number of Cycles:- Until Disease Progression
Control Intervention1: Low Dose Cytarabine Plus Volasertib Matching Placebo: 2 x 20 mg (total 40 mg/day) Days 1 to 10 in 28-day c
subcutaneous injection Plus Single dose
intravenous infusion (1 hour).
Number of Cycles:- Until Disease Progression
Control Intervention2: Volasertib matching placebo: Single dose
intravenous infusion (1 hour)
Sponsors
Boehringer Ingelheim Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: • Age >= 65 years • Cytologically/histologically confirmed AML according to WHO classification except for Acute promyelocytic leukemia (APL) • Investigator considers patient ineligible for intensive remission induction therapy based on documented medical reasons (e.g. disease characteristics like AML genetics, type of AML (de novo or secondary), and patient characteristics like performance score, concomitant diagnoses, organ dysfunctions • Patient is eligible for LDAC treatment • ECOG performance score • Previously untreated AML except for hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative). Previous therapy for MDS is allowed
Exclusion criteria
Exclusion criteria: • Prior or concomitant chemotherapy for AML Prior therapy for MDS is allowed. • Treatment with any investigational drug within 2 weeks before first administration of present trial drug • APL (Acute promyelocytic leukemia) • Hypersensitivity to one of the trial drugs or the excipients • Current clinical central nervous system symptoms deemed by the investigator to be related to leukemic CNS involvement • Severe illness or organ dysfunction involving the heart, kidney, liver or other organ system which in the opinion of the investigator precludes treatment with LDAC • QTcF prolongation > 470 ms or QT prolongation deemed clinically relevant by the investigator • Total Bilirubin > 3 x ULN • Creatinine clearance • Active Hepatitis B or Hepatitis C or chronic infection • HIV infection • Second malignancy currently requiring active therapy • Any significant concurrent psychiatric disorder or social situation that according to the investigator judgement would compromise patient safety or compliance interfere with consent study participation or interpretation of study results • Known or suspected active alcohol or drug abuse, • Patient unable to comply with the protocol • Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial and for a minimum of 6 months after study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Remission (CR) and Complete Remission with incomplete blood count recovery (CRi), based on blinded central review Timepoint: Complete Remission-Cycle-1 till end of treatment Complete Remission with incomplete blood count recovery-Cycle-1 till end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoint: Overall Survival (OS). Secondary endpoints: Event-Free Survival (EFS), Relapse-Free Survival (RFS). Timepoint: Key secondary endpoint: Overall Survival (OS). Secondary endpoints: Event-Free Survival (EFS), Relapse-Free Survival (RFS). | — |
Countries
Argentina, Austria, Brazil, Czech Republic, Finland, Greece, Hungary, Japan, Mexico, Netherlands, Norway, Poland, Russian Federation, South Africa, Taiwan, Thailand, United States of America
Contacts
Public ContactDr Partha Gokhale
Boehringer Ingelheim Pvt Ltd
Outcome results
None listed