Phase 3
Completed N=666
Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)
Leukemia, Myeloid, Acute
Source: ClinicalTrials.gov NCT01721876 ↗
Enrolled (actual)
666
Serious AEs
82.2%
Results posted
Nov 2021
Primary outcomePrimary: Objective Response (OR) — 38; 123 Participants — p=0.0024
◆ Published Evidence
Established
39citations · ~8 / year
The Polo-like kinase 1 inhibitor onvansertib represents a relevant treatment for head and neck squamous cell carcinoma resistant to cisplatin and radiotherapy.
Summary
To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low dose cytarabine in patients >= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy
Linked Publications
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The Polo-like kinase 1 inhibitor onvansertib represents a relevant treatment for head and neck squamous cell carcinoma resistant to cisplatin and radiotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response (OR) |
38; 123 | 0.0024 sig |
| SECONDARY Overall Survival (OS) |
6.5; 5.6 | 0.7571 |
| SECONDARY Event-free Survival (EFS) |
2.8; 3.3 | 0.6718 |
| SECONDARY Relapse-free Survival (RFS) |
18.7; 13.1 | — |
Eligibility Criteria
Inclusion criteria
- Age >= 65years.
- Cytologically/histologically confirmed acute myeloid leukaemia (AML) according to WHO classification; (except for acute promyelocytic leukaemia (APL).
- Previously untreated AML (except for hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Previous therapy for Myelodysplastic Syndrome (MDS) is allowed.
- 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 Low-Dose Cytarabine (LDAC) treatment.
- Eastern co-operative oncology group (ECOG) performance score 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome).The QTcF will be calculated as the mean of the 3 Electrocardiogram (ECGs) taken at screening.
- Total bilirubin > 3 x upper limit of normal (ULN).
- Creatinine clearance (CLcr) < 30 ml/min (estimated creatinine clearance by the Cockcroft-Gault (C-G) equation) .
- Active hepatitis B or hepatitis C, or laboratory evidence for a chronic infection.
- HIV infection.
- Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment e.g. in prostate or breast cancer).
- Any significant concurrent psychiatric disorder or social situation that according to the investigator´s judgement would compromise patient´s 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, in the opinion of the investigator.
- 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.
Data sourced from ClinicalTrials.gov (NCT01721876) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.