NL-OMON47695
Recruiting
Phase 2
A Phase I/II study of Azacitidine (Vidaza®) in pediatric patients with relapsed high-grade pediatric MDS or JMML - Azacitidine in pediatric MDS/JMM
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- MDS and JMML
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 3
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of relapsed advanced primary MDS or JMML, established at initial
- •diagnosis by the diagnostic criteria as specified in the EWOG\-MDS 2006 protocol
- •(see appendix 1\), and defined as:
- •o Relapsed MDS:
- •After a documented CR or PR, this designation is defined as
- •\- a reappearance of blasts in the peripheral blood,
- •\- or \>\=5% blasts in the bone marrow not attributable to any other cause (e.g.
- •bone marrow regeneration after consolidation therapy), and confirmed with
- •flowcytometry.
- •o Relapsed JMML:
Exclusion Criteria
- •Other serious illnesses or medical conditions
- •Genetic abnormalities indicative of AML
- •JMML patients in whom a diagnosis of Noonan syndrome is suspected based on
- •clinical history and/or presenting symptoms
- •Patients with secondary MDS with underlying bone\-marrow failure syndromes
- •or with familial MDS
- •Isolated extramedullary disease
- •Symptomatic CNS\-involvement
- •Current uncontrolled infection
- •Cardiac toxicity (shortening fraction below 28%)
Outcomes
Primary Outcomes
Not specified
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