intravenous volasertib in combination with subcutaneous low-dose cytarabine vs. placebo plus low-dose cytarabine in patients â?¥ 65 years with previously untreated acute myeloid leukaemia,who are ineligible for intensive remission induction therapy
- Conditions
- Health Condition 1: null- Acute Myeloid Luekemia
- Registration Number
- CTRI/2014/01/004298
- Lead Sponsor
- Boehringer Ingelheim Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 35
•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 <= 2 at screening
•Previously untreated AML except for hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative).
Previous therapy for MDS is allowed
•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 < 30 mL per min
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete Remission (CR) and Complete Remission with incomplete blood count recovery (CRi), based on blinded central review <br/ ><br>Timepoint: Complete Remission-Cycle-1 till end of treatment <br/ ><br>Complete Remission with incomplete blood count recovery-Cycle-1 till end of treatment
- Secondary Outcome Measures
Name Time Method Key secondary endpoint: Overall Survival (OS). <br/ ><br> <br/ ><br>Secondary endpoints: Event-Free Survival (EFS), Relapse-Free Survival (RFS). <br/ ><br>Timepoint: Key secondary endpoint: Overall Survival (OS). <br/ ><br> <br/ ><br>Secondary endpoints: Event-Free Survival (EFS), Relapse-Free Survival (RFS). <br/ ><br>