Study to treat the molecular relapsed of AML patients in childhood with Azacitidine
- Conditions
- 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).MedDRA version: 20.0Level: PTClassification code 10059034Term: Acute myeloid leukaemia recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2017-003422-32-DK
- Lead Sponsor
- Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH) gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 20
1. Aged 3 months to <21 years with documented diagnosis of AML according to WHO classification with at least one quantitative genetic maker, e.g. one of the following aberrations:
• t(8;21); RUNX1/RUNX1T1
• inv(16); CBFb/MYH11
• t(9;11); MLL/AF9
• t(10;11); MLL/AF10
• NPM1
• WT1; etc.
2. Molecular remission (MRD in PB less than 5 x 10-4) confirmed at the start of last consolidation course or within 1 month after completion of consolidation treatment
3. Detection of a confirmed molecular relapse of an AML
4. Understand and voluntarily provide permission (subjects and when applicable, parental/legal representative(s)) to the ICF prior to conducting any study related assessments/procedures
5. Able to adhere to the study visit schedule and other protocol requirements
6. Lansky performance score at least equal to 50; or Karnofsky performance status at least equal to 50, whichever is applicable
7. Negative serum pregnancy tests for females of child bearing potential within 10 days prior to treatment
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
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
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 the active substance or other excipients contained in the investigational medical product listed in the summary of product characteristics (SmPC) or Investigators Brochure (IB).
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 using highly effective anticonceptive measure(ment)s
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method