EUCTR2015-004625-14-NLActive, not recruitingPhase 1
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
Boehringer Ingelheim bv0 sites52 target enrollmentStarted: May 9, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 52
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 42
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
Investigators
Similar Trials
Active, not recruiting
Phase 1
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 failedPaediatric AML after first-line failureEUCTR2015-004625-14-DEBoehringer Ingelheim Pharma GmbH & Co. KG99,999
Active, not recruiting
Phase 1
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 failedEUCTR2015-004625-14-DKBoehringer Ingelheim Pharma GmbH & Co. KG52
Active, not recruiting
Phase 1
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 failedEUCTR2015-004625-14-BESCS Boehringer Ingelheim Comm.V99,999
Active, not recruiting
Phase 1
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 failedAcute myeloid leukaemia after failure of front-line therapy in paediatric patientsEUCTR2015-004625-14-ITBoehringer Ingelheim Italia S.p.A.52
Active, not recruiting
Phase 1
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 failedAcute myeloid leukaemia after failure of front-line therapy in paediatric patientsEUCTR2015-004625-14-CZBoehringer Ingelheim RCV GmbH & Co KG52