EUCTR2005-004811-31-IT
Active, not recruiting
Not Applicable
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
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL ADULTO0 sites56 target enrollmentStarted: November 28, 2006Last updated:
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL ADULTO
- Enrollment
- 56
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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