drugset / Trial / NCT00923234

Combination of 5-azacitidine and Lenalidomide in Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML) Myelodysplastic Syndromes

NCT00923234 ↗

NaSingle-groupOpen-labelTreatment

Summary

The hypothesis of this study is that 5-aza and lenalidomide act synergistically in MDS and AML patients with chromosomal abnormalities involving monosomy 5 or del5q. Therefore, this phase I study will investigate the maximum tolerated dose (MTD) of lenalidomide in combination with a fixed dose of 5-aza in this patient population.

Timeline

Start
2009-06
Primary completion
2012-07
Completion
2012-07

Outcome

Outcome not reported

Stopped (Enrollment): “The primary objective has already been answered with the number of recruited patients.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 75 mg/m2 Subcutaneous
Subject Lenalidomide Other / unclassified 10 mg Oral
Subject Lenalidomide Other / unclassified 25 mg Oral