MedTrace Logo

5-Azacitidine in Low-risk Myelodysplastic Syndromes (MDSs)

NCT00897130 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2014-12-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Azacytidine

Azacitidine will be given at a dose of 75mg/sqm subcutaneous daily for 5 consecutive days every 28 days (every month) for a total of 8 courses. 5-Aza dosages will be adjusted

Sponsors & Collaborators

  • University of Udine

    collaborator OTHER

  • University of Bologna

    collaborator OTHER

  • University of Genova

    collaborator OTHER

  • University of Siena

    collaborator OTHER

  • Cremona

    collaborator UNKNOWN

  • Mantova

    collaborator UNKNOWN

  • Università degli Studi di Brescia

    lead OTHER

Principal Investigators

  • Prof Domenico Russo, MD · Chair of Haematology, Brescia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-12-31
Completion
2014-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00897130 on ClinicalTrials.gov