?Clinical and biological effects of 5-Azacitidine five days/monthly schedule in symptomatic low-risk myelodysplastic syndromes (MDSs)? - MDS0706

• Conditions: Adlut patients with low risk MDS (IPPS 0-1); MedDRA version: 9.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disorders

• Registration Number: EUCTR2007-003943-55-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with low-risk (IPSS 0-INT1) MDS according to WHO classification, presenting one or more of the followings:
-Symptomatic anemia requiring RBC transfusion supportive therapy previously unresponsive to EPO or not expected to respond to EPO,
-Thrombocytopenia requiring platelet transfusion with or without muco-cutaneous haemorragic syndrome.
Persistent (>3 months) absolute neutrophil count less then 1,5 x 109/L , with or without infections, requiring or not myeloid growth factor therapy.
≥18 years old.
Life expectancy≥3months.
ECOG performance Status Grade 0-2.
Serum bilirubin levels ≤1.5 upper limit of the normal (ULN)
Serum GOT and GPT levels ≤ 2x UNL.
Creatinine levels ≤1.5x UNL.
Negative serum β-human chorionic gonadotropin (β-HCG) pregnancy test 24 hours prior to beginning of therapy with 5-AZA, for fertile women.
Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with MDS according to WHO classification with INT-2 or high IPSS risk.
Life expectancy < 3months;
ECOG performance Status Grade > 2;
Serum bilirubin levels >1.5 upper limit of the normal (ULN);
Serum GOT and GPT levels > 2 x UNL;
Creatinine levels >1.5 x UNL;
Pregnancy or breast feeding
Insulin-dependent diabetes and uncontrolled non insulin-dependent diabetes;
Severe cardiac or pulmonary disease incompatible with the conduction of the protocol;
Patient with a clear indication to receive long-term anticoagulant therapy;
Other active hematologic or solid tumors;
Severe CNS disease;
Malignant hepatic tumors
Hypersensitivity to mannitol or azacitidine
No written informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy (hematologic response), and toxicity of five days monthly 5-Aza treatment schedule in patients with low-risk MDS (IPSS 0-1).;Secondary Objective: To evaluate the QoL by the FACT-An questionnaire<br>To evaluate time to progression of MDS<br>To evaluate the gene expression profile of MDS patients sensitive or resistant to 5-Aza<br>To evaluate oncostatin M, interleukin-6 and interleukin-11 levels in the responders and non responders;Primary end point(s): therapy respnse according to Cheson (Blood, 2006); SAE number and grade