Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, dose-escalating trial to evaluate 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. Furthermore, data on efficacy and PK/PD of volasertib in paediatric patients with AML when added to standard intensive salvage chemotherapy will be collected.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Volasertib | Drug | Volasertib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Volasertib
- interventionNames
- Drug: Volasertib
Primary outcomes (1)
- measure
- Determination of the maximal tolerated dose 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
- timeFrame
- 4 weeks
Secondary outcomes (9)
- measure
- Anti-leukaemic activity of volasertib in combination with standard salvage therapy
- timeFrame
- 8 weeks
- measure
- Event-free survival (EFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Months
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion criteria: * Patients 3 months to \<18 years of age at the time of informed consent * Patients with AML after failure of the front-line intensive AML therapy * Lansky score at screening \>=50 for patients from 3 months to \<12 years * Karnofsky score at screening \>=50 for patients from 12 to \<18 years * Use of highly effective methods of birth-control, if sexually active * Parents/legal guardians and patients have given written informed consent and informed assent suitable for the respective age group 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 * Further exclusion criteria apply
References
Publications (0)
Data not yet available