An open label, phase II, non randomized, clinical trial of chemotherapy treatment with 5-Azacytidine plus valproic acid and eventually atra for patients diagnosed with Intermediate II and high risk Myelodysplastic syndrome MDS - GIMEMA Protocol MDS 0205

• Conditions: Intermediate II and high risk Myelodysplastic syndrome MDS; MedDRA version: 8.1Level: PTClassification code 10028533Term: Myelodysplastic syndrome

• Registration Number: EUCTR2005-004811-31-IT
• Lead Sponsor: G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL ADULTO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-28
• Last Update Posted: 30 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

- Have a diagnosis of refractory anemia with excess blasts RAEB or refractory anemia with excess blasts in transformation RAEB-t according to the French-American-British classification system for MDS with an International Prognostic Scoring System score of INT-2 or High Appendix C or diagnosis of Myelodysplastic CMMoL per a modified FAB criteria Appendix B and a relatively high risk of AML transformation,; Age 8805;18 years; life expectancy 8805;3 months; Be unlikely to proceed to bone marrow or stem cell transplantation therapy following remission; Signed written informed consent according to IGH/EU/GCP and national local laws; Eastern Cooperative Oncology Group Performance Status Grade of 0-2 Appendix D ; Serum bilirubin levels 8804;1.5 x the upper limit of the normal ULN range for the laboratory; higher levels are acceptable if these can be attributed to active hemolysis as indicated by positive direct Coombs testing, decreased haptoglobin level, elevated indirect bilirubin and/or lactate dehydrogenase , or ineffective erythropoiesis as indicated by bone marrow findings ; Serum glutamic-oxaloacetic transaminase aspartate aminotransferase or serum glutamic-pyruvic transaminase alanine aminotransferase levels 8804;2 x ULN; Women of childbearing potential may participate, providing they meet the following conditions - Must not start a pregnancy throughout the study and for 6 months following the date of the last dose of study medications; - Must have a negative serum pregnancy test obtained within 48 hours prior to Day 1. Males with female partner of childbearing potential must avoid fathering throughout the study and for 6 months following the date of the last dose of study medication.
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

-acute myeloid leukaemia i.e. bone marrow blasts 30 ; -concurrent malignancy diagnosed in the past 12 months with the exception of skin basalioma ; -severe renal impairment creatinine clearance 30 ml/min ; -pregnant or lactating, or are potentially fertile both males and females and have not agreed to avoid pregnancy during the trial period; -they have liver disease characterized by AST and ALT level 2X ULN and total bilirubin 1.5X ULN unless due to active hemolysis or ineffective erythropoiesis; -HIV infection; -active, uncontrolled HCV or HBV infections or liver cirrhosis; -clinically relevant neurological diseases; -psychiatric illness that would prevent granting of informed consent; -hypersensitivity known or suspected to Azacytidine or Mannitol -prior Treatments Prior investigational drugs within 30 days Radiation therapy, chemotherapy, or cytotoxic therapy for non- MDS conditions within the previous 6 months Growth factors EPO, G-CSF or GM-CSF during the previous 21 days Androgenic hormones during the previous 14 days Prior transplantation or cytotoxic therapy, including azacitidine and chemotherapy, administered to treat MDS.

Study & Design

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