Two parts study, the first part is to determine the dose of azacitidine and the second part is to evaluate the effect of azacitidine compared to no treatment, in children and young adults following a molecular relapse of acute myeloid leukemia after the first complete remission.
- Conditions
- Treatment of children and young adults with molecular relapse of acute myeloid leukemia(AML) after first complete remission (CR1).MedDRA version: 20.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-002172-92-DE
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
•Patients= 3months and less than 21 years old, who (subject and when applicable parental/ legal representative(s)) must understand and voluntarily sign an Informed Consent or Informed Assent Form.
Note: for the Safety Run-in, Patients= 3months and less than 18 years old at the time of informed consent/assent
•At the time of signing the ICF/IAF, patients must have documented diagnosis of Acute Myeloid Leukemia and documentation of molecular remission confirmed at the start of last consolidation course or within 1 month after completion of consolidation treatment.
•Safety Run-In (At the time of signing ICF/IAF): Detection of molecular relapse within 7 days prior to signing consent/assent and confirmation of molecular relapse during the screening period.
Randomized Part (At the time of pre-drug verification visit); Detection of molecular relapse within 7 days prior to signing consent/assent and confirmation of molecular relapse during the screening period.
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
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
•Concomitant treatment with any other anticancer therapy except those specific in protocol and no maintenance therapy after end of consolidation therapy and confirmed remission.
•Hematopoietic Stem Cell Transplantation within previous 3 months
•Pregnant or breastfeeding females
•Patients with a current disease that can interfere with protocol procedures or study treatment
•Hypersensitivity to azacitidine
•Symptomatic CNS-involvement or isolated extramedullary disease at initial diagnosis.
•FAB type M3 leukemia (acute promyelocytic leukemia)
•Therapy-related AML
•AML of Down syndrome or other congenital syndromes giving rise to leukemia or treatment complications.
•Symptomatic cardiac disorders (CTCAE Grade 3 or 4).
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