Status:
COMPLETED
5-Azacitidine in Low-risk Myelodysplastic Syndromes (MDSs)
Lead Sponsor:
Università degli Studi di Brescia
Collaborating Sponsors:
University of Udine
University of Bologna
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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, sev...
Detailed Description
5-Azacitidine(5-AZA) is the most promising drug for treatment MDSs. When administered at a dose of 75mg/m2/day subcutaneously for 7 days, every 28 days (every month), 5-Aza produces high rates of tril...
Eligibility Criteria
Inclusion
- 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 haemorrhagic 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 ≥ 3 months.
- 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.
Exclusion
- Patients with MDS according to WHO classification with INT-2 or high IPSS risk.
- Life expectancy \< 3 months.
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00897130
Start Date
August 1 2008
End Date
December 1 2014
Last Update
December 3 2014
Active Locations (7)
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1
University of Bologna
Bologna, Italy
2
Chair of Haematology, Bone Marrow Transplant Unit
Brescia, Italy, 25123
3
Cremona
Cremona, Italy
4
University of Genova
Genova, Italy