Intravenous azacitidine 100 mg/m2, Days 1 to 7 of a 28-day cycle for up to 3 cycles initially. In case of decline of MRD during azacitidine treatment additional cycles are allowed (maximum 6 cycles).
Conditions
Interventions
Trade Name: Vidaza
Product Name: Azacitidine
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: AZACITIDINE
CAS Number: 320-67-2
Concentration unit: mg/ml milligram(s)/millilit
Sponsors
Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH) gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 3 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Concomitant treatment with any other anticancer therapy except those specified in protocol 2. HSCT within previous 3 months 3. Treated by any investigational agent in a clinical study within previous 4 weeks 4. Pregnancy or lactating 5. FAB type M3 leukemia (acute promyelocytic leukemia) 6. Therapy-related AML 7. AML of Down syndrome or other congenital syndromes giving rise to leukemia or treatment complications 8. Symptomatic cardiac disorders (CTCAE 4.0 Grade 3 or 4) 9. Evidence of invasive fungal infection or other severe systemic infection requiring treatment doses of systemic/parenteral therapy including known active viral infection with human immunodeficiency virus (HIV) or Hepatitis Type B and C 10. Any other organ dysfunction (CTCAE 4.0 Grade 3 or 4) that will interfere with the administration of the therapy according to this protocol 11. Ongoing severe toxicities (CTCAE 4.0 Grade 3 or 4) of prior chemotherapy/stem cell transplantation 12. Hypersensitivity to azacitidine 13. Abnormal liver function: • serum bilirubin > 3 x ULN • ALT or AST > 5 times ULN 14. Symptomatic CNS-involvement or isolated extramedullary disease at initial diagnosis 15. Female and male subjects with child bearing potential who avoid to use secure anti-conceptive measurements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of azacitidine treatment in AML subjects at molecular relapse after CR1 with regard to molecular response prior to further treatment (reinduction / HSCT);Secondary Objective: To assess safety of azacytidine treatment in children and adolescents with a molecular relapse of AML. Disease free and overall survival post molecular relapse; quality of life (questionnaire, AE reports).;Primary end point(s): The primary endpoint based on molecular response will be assessed at the end of the azacitidine treatment.;Timepoint(s) of evaluation of this end point: after max. 196 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Toxicities • Event-free-survival • Disease free survival • Overall-survival • Quality of life ;Timepoint(s) of evaluation of this end point: after max. 196 Days | — |
Countries
Austria, Belgium, Czech Republic, Denmark, European Union, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, United Kingdom
Contacts
Public ContactKatharina Waack-Buchholz
Päd. Forschungsnetzwerk
Outcome results
None listed