5-azacytidine Valproic Acid and ATRA in AML and High Risk MDS

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

MULTICENTERS. Uncontrolled and open phase II study. Evaluation of the effectiveness of a treatment associating 5 Azacytidine,Valproic acid ,Retinoic Acid at subjects-reached of syndromes myelodysplasia and acute MYELOID leukaemia Hematological response at 6 months Uncontrolled prospective cohort.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Azacitidine; Tretinoin; Valproic Acid

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