drugset / Trial / NCT01053806
Safety And Efficacy Of Azacitidine, and Lenalidomide In Higher Risk Myelodysplastic Syndrome
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2011-08
- Primary completion
- 2014-03
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 5-Azacytidine | Small molecule | 75 mg/m2 | Subcutaneous |
| Subject | Lenalidomide | Other / unclassified | 10 mg | Oral |