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Lenalidomide Combined with Azacitidine in High Risk MDS with Del 5q
NCT01088373Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2010
- Primary completion
- Jul 2016
- Countries
- 1
- Sponsor
- Groupe Français des Myélodysplasies
- Modality
- Small Molecules
- Drugs
- lenalidomide
- Conditions
- myelodysplastic syndrome (MDS)
01
Overview
Phase 2, open-label, single-arm trial of lenalidomide in myelodysplastic syndrome (MDS), sponsored by Groupe Français des Myélodysplasies. Primary endpoint: Safe Most Successful Dose at 4 months. Started Mar 2010; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Azacitidine + Lenalidomide
Azacitidine 75mg/m2/d x 5d + Lenalidomide (5-10mg)
03
Who it enrols
Patients aged 18-75 with Intermediate-2 or High Risk MDS and del(5q), ineligible for or having failed intensive chemotherapy.
04
Endpoints
Primary
Safe Most Successful Dose
Secondary
Response Rate
Safety
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