A study to find a safe dose of volasertib given in addition to standard salvage chemotherapy in children (age 3 months to less than 18 years) with acute myeloid leukaemia, in whom front-line chemotherapy failed

Open-label, dose-escalating trial to evaluate the tolerability, toxicity, safety, pharmacokinetics, pharmacodynamics and activity of volasertib added to the standard intensive salvage chemotherapy regimen with liposomal daunorubicine, fludarabine and cytarabine (DNX-FLA) followed by fludarabine and cytarabine (FLA) in children from 3 months to less than 18 years of age with acute myeloid leukaemia after failure of the front-line therapy

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004625-14-DE

Enrollment

Registered

2016-02-02

Start date

2016-07-05

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatric AML after first-line failure

Interventions

Product Name: volasertib Product Code: BI 6727 Pharmaceutical Form: Solution for infusion INN or Proposed INN: volasertib Current Sponsor code: BI 6727 Other descriptive name: BI 6727 Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients 3 months to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Down syndrome - Acute promyelocytic leukaemia and treatment-related AML - QTc prolongation - LVSF <30% - Cardiac disease and/or dysfunction - Active uncontrolled infection - HIV infection, acute or chronic hepatitis - Inadequate lab parameters - Impaired renal function - Pregnancy or nursing

Design outcomes

Primary

Measure	Time frame
Main Objective: To define the MTD and/or dose to be used for further development by evaluation of DLT in course 1 and the safety of volasertib when added to standard intensive salvage chemotherapy with DNX-FLA in paediatric patients with AML after failure of first-line therapy;Secondary Objective: To collect data on efficacy and PK/PD of volasertib in paediatric patients with AML when added to standard intensive salvage chemotherapy;Primary end point(s): 1: Determination of the MTD of volasertib or the recommended volasertib dose for further studies in combination with standard salvage therapy in paediatric patients with AML after failure of the front-line intensive chemotherapy regimen ;Timepoint(s) of evaluation of this end point: 1: 4 weeks	—

Measure

Time frame

Main Objective: To define the MTD and/or dose to be used for further development by evaluation of DLT in course 1 and the safety of volasertib when added to standard intensive salvage chemotherapy with DNX-FLA in paediatric patients with AML after failure of first-line therapy;Secondary Objective: To collect data on efficacy and PK/PD of volasertib in paediatric patients with AML when added to standard intensive salvage chemotherapy;Primary end point(s): 1: Determination of the MTD of volasertib or the recommended volasertib dose for further studies in combination with standard salvage therapy in paediatric patients with AML after failure of the front-line intensive chemotherapy regimen ;Timepoint(s) of evaluation of this end point: 1: 4 weeks

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Secondary

Measure	Time frame
Secondary end point(s): 1: Number of patients with clinically relevant lab value changes of calcium (hyper- and/or hypocalcaemia) as judged by the investigator and reported as adverse events (CTCAE grade 3 or higher) 2: Number of patients with changes in cardiac activity (prolonged QTc interval) reported as clinically relevant observations (i.e. AEs) 3: Anti-leukaemic activity of volasertib in combination with standard salvage therapy 4: Event-free survival (EFS) 5: Overall survival (OS) 6: Pharmacokinetic evaluation of volasertib ;Timepoint(s) of evaluation of this end point: 1: 8 weeks 2: 8 weeks 3: 8 weeks 4: up to 5 years 5: up to 5 years 6: 8 weeks	—

Measure

Time frame

Secondary end point(s): 1: Number of patients with clinically relevant lab value changes of calcium (hyper- and/or hypocalcaemia) as judged by the investigator and reported as adverse events (CTCAE grade 3 or higher) 2: Number of patients with changes in cardiac activity (prolonged QTc interval) reported as clinically relevant observations (i.e. AEs) 3: Anti-leukaemic activity of volasertib in combination with standard salvage therapy 4: Event-free survival (EFS) 5: Overall survival (OS) 6: Pharmacokinetic evaluation of volasertib ;Timepoint(s) of evaluation of this end point: 1: 8 weeks 2: 8 weeks 3: 8 weeks 4: up to 5 years 5: up to 5 years 6: 8 weeks

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Countries

Belgium, Czech Republic, Denmark, France, Germany, Italy, Netherlands

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim Pharma GmbH & Co. KG

clintriage.rdg@boehringer-ingelheim.com0018002430127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026