A Phase I Study of a Combination of 5-azacitidine Followed by Lenalidomide in High-risk MDS or Relapsed/Refractory AML Patients With Cytogenetic Abnormalities Including -5 or Del(5q)
Cytogenetics are the main predictors of outcome in patients with AML. In fact, a monosomy 5
or del (5q) as single aberration are poor prognostic markers. Overall, the complete response
rate for conventionally treated patients with newly-diagnosed AML with chromosome 5
abnormalities is about 31% to 37 % and all patients rapidly relapse if not rescued by
allogeneic HSCT. The situation is almost similar in patients with high-risk MDS.Vidaza® has
been shown in clinical trials to achieve remission rates in about 29% (CR+PR) of the
patients while a total of 49% achieve improvement of blood counts.Revlimid® is also able to
achieve complete remissions in advanced MDS and even overt leukemia with or without
chromosome 5 abnormalities. Nevertheless, response rates are lower compared to low-risk MDS
(IPSS Low/INT-1). Therefore, Revlimid® seems to be too weak as a single agent, but a
promising compound for a combination therapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) of Revlimid® (lenalidomide)in combination with Vidaza®(5-azacitidine)
during first cycle of therapy
Yes
Uwe Platzbecker, MD
Principal Investigator
Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus
Germany: Federal Institute for Drugs and Medical Devices
TUD-AZALE1-037
NCT00923234
June 2009
July 2013
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