Azacitidine/Lenalidomide

To evaluate the overall response rate of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients (INT-2 and High risk defined by IPSS), and patients with low and int-1 who are considered to be at high risk due to unfavorable additional factors.
To evaluate the safety of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients.
To evaluate the hematological improvement rate.
To evaluate the cytogenetic response rate.
To evaluate the Progression free survival (PFS).
To assess Quality of life.

Higher risk MDS with del(5q) carry very poor prognosis, but show some response to azacitidine and Lenalidomide as single agents . The combination of Lenalidomide and Azacytidine is currently tested in non del 5q MDS patients. Preliminary results have been recently presented at ASH meeting (Sekeres et al, 2007).
Overall, the combination of Lenalidomide and Azacitidine is well-tolerated and early results suggest some efficacy in advanced MDS without del 5q.
In this trial, we will combine Lenalidomide to Azacytidine in higher risk MDS with del (5q).
Patients will receive azacitidine( 75mg/m2/day for 5 days every 28 days) combined to escalating doses of lenalidomide (starting at relatively low dose).
For patients in hematological CR, PR, HI or marrow CR after cycle 2 or 4, it is mandatory to continue on Azacitidine + Lenalidomide as long as there is no unacceptable toxicity or overt progression, with the schedule that yielded response.
In patient still responding after 52 weeks, the drug will continue to be supplied, and follow up until death will be continued in all patients.