A phase I study of azacitidine with Ceplene/interleukin-2 will first evaluate the safety and tolerability of this regimen in patients with higher risk myelodysplastic syndromes (MDS) who achieved a hematological response after 6 cycles of azacitidine. After approval by an independent Data Safety Monitoring Board (DSMB), the phase I study will be followed by an open label randomized phase II study designed to characterize the efficacy, safety, and tolerability of the addition of Ceplene/interleukin-2 to azacytidine in patients with higher risk myelodysplastic syndrome (MDS) who achieved a hematological response after 6 cycles of azacitidine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Azacitidine: 75 mg/m2 subcutaneously daily for 7 days every 4 weeks. Ceplene® / IL2: Patients will receive Ceplene at 0.5 mg subcutaneous twice daily and human recombinant IL-2 at 16 400 U/kg subcutaneous twice daily during 15 days for up to 10 cycles, on days 8 to 21 of AZA cycles.
Azacitidine 75 mg/m2 subcutaneously daily for 7 days every 4 weeks
CHU d'Amiens
Amiens, France
Time to progression according to IWG2006 criteria
Progression will be assessed by monitoring the bone marrow, blood and hematologic supportive care according IWG 2006 criteria .
Time frame: Every 4 cycles (during average 2 years)
Types and numbers of adverse events occuring in all treated patients
The safety profile will be determine by assessements of clinical symptoms, physical examinations, vital signs and clinical laboratory tests. The types and numbers of adverse events occuring in all treated patients will be tabulated.
Time frame: Every cycle, during the follow-up on average during 2 years
Improvement of the quality and the duration of responses compared to maintenance with AZA alone
The response will be assessed every 4 cycles according IWG 2006 criteria and it will be evaluated if there is an improvement of the level of response and the response duration
Time frame: While patient is on study, during follow up on average during 2 years
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