drugset / Trial / NCT00897130
5-Azacitidine in Low-risk Myelodysplastic Syndromes (MDSs)
Phase 2
Completed
28 enrolled
University of Brescia
Cremona · collabMantova · collabUniversity of Bologna · collabUniversity of Genova · collabUniversity of Siena · collabUniversity of Udine · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Azacitidine will be given at a dose of 75 mg/sqm (s.c) daily for 5 consecutive days every 28 days (every month) for a total of 8 courses to low risk MDSs according to IPSS scoring system. In fact, several studies produced high rates of trilineage responses, reduces the risk of progression to acute myeloid leukemia (AML) in high-risk MDS and improves the quality of life (QoL). The use of 5-Aza in the earlier phases of MDS could reduce the proliferative advantage of MDS clone and favour the regrowth of normal hematopoiesis.
Timeline
- Start
- 2008-08
- Primary completion
- 2009-12
- Completion
- 2014-12
Publications
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |