EUCTR2010-022235-10-DK
Active, not recruiting
Phase 1
A Phase I/II study of Azacitidine (Vidaza®) in pediatric patients with newly diagnosed or relapsed high-grade pediatric MDS or JMML - Azacitidine in high grade MDS and JMML pediatric patients
Drugsvidaza
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC
- Enrollment
- 65
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In this study 4 subgroups of patients are eligible, which will be enrolled in 4 different strata:
- •stratum 1: newly diagnosed patients with advanced MDS (RAEB or RAEB\-t) in a ‘pre stem cell transplantation window’.
- •stratum 2: relapsed patients with advanced MDS in a ‘re\-transplantation window’. At relapse azacitidine may also be continued when a 2nd transplant is not feasible, as long as the patient benefits from treatment.
- •stratum 3: newly diagnosed patients with JMML in a ‘pre\-stem cell transplantation window’.
- •stratum 4: relapsed patients with JMML in a ‘re\-transplantation window’. Azacitidine may also be continued when a 2nd transplant is not feasible and as long as the patient benefits from treatment.
- •straum 5:newly diagnosed or relapsed patients with secondary advanced MDS, occurring after
- •chemotherapy, radiotherapy and or stem\-cell transplantation, or secondary cases after
- •prior treatment for aplastic anemia. Note: secondary MDS cases after bone\-marrow failures or familial cases are not eligible
- •General conditions:
- •Advanced primary or secondary MDS or JMML confirmed by the diagnostic criteria as specified in the EWOG\-MDS 2006 protocol (see appendix 1\)
Exclusion Criteria
- •Prior or current history:
- •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%)
- •Concurrent treatment with any other anti\-cancer therapy is not allowed
Outcomes
Primary Outcomes
Not specified
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