5-azacytidine Valproic Acid and ATRA in AML and High Risk MDS
Acute Myelogenous Leukaemia (AML), Myelodysplastic Syndrome (MDS)
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukaemia (AML) focused on measuring AML, MDS High risk, Demethylating agents, HDAC Inhibitors
Eligibility Criteria
Inclusion Criteria: Patients ≥ 18 years high Risk Acute Myelogenous Leukemia (FAB-M3 excluded), including : AML in first relapse in patients with secondary AML(after MDS and CMML) AML in first relapse in patients with a CR duration < 12 months Second Relapse or > 2 de novo AML without previous treatment in elderly patients (FAB-M3 excluded) , if : 70 years with de novo AML or secondary AML (Transformation of myelodysplasia) Unfit for Intensive chemotherapy High risk myelodysplasia, including : RAEB or t-RAEB (FAB) With IPSS score Intermediate-2 or High risk (Greenberg, 1997) non eligible for allogeneic HSC transplantation Women of childbearing potential (WOBP) must be using an adequate method of contraception Men with WOBP have to use an acceptable method to avoid pregnancy Signed Written informed consent Exclusion Criteria: APL(FAB) Clinical CNS involvement Uncontrolled infectious disease Adequate hepatic function defined as total bilirubin < 3 times ULN ALAT and ASAT < 2.5 times ULN Adequate renal function (serum creatinine < 1.5x ULN anc Creatinine clearance < 25ml/min) Included in an other clinical trial Previous treatment with 5-aza &/or Valproic acid &/or retinoic acid Positive pregnancy test Women who are breastfeeding
Sites / Locations
- Chu Saint Louis
Arms of the Study
Arm 1
Experimental
1
5-azacytidine VALPROIC acid and ATRA