EUCTR2010-022235-10-ES
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
ConditionsAdvanced Myelodysplastic Syndromes (MDS) and Juvenile Myelomonocytic Leukemia (JMML)MedDRA version: 17.1Level: LLTClassification code 10054439Term: Juvenile chronic myelomonocytic leukemiaSystem Organ Class: 100000004864MedDRA version: 17.1Level: LLTClassification code 10068361Term: MDSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Drugsvidaza
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced Myelodysplastic Syndromes (MDS) and Juvenile Myelomonocytic Leukemia (JMML)
- Sponsor
- Erasmus MC
- Enrollment
- 5
- Status
- Active, not recruiting
- Last Updated
- 3 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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