Status:
COMPLETED
5-azacytidine Valproic Acid and ATRA in AML and High Risk MDS
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Myelogenous Leukaemia (AML)
Myelodysplastic Syndrome (MDS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 myelodysplasi...
Detailed Description
Chromatin Demethylation Apart from histone acetylation deacetylation, promoter hypermethylation is another important and relevant mechanism involved in gene transcription regulation (reviewed in Herma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00339196
Start Date
July 1 2006
End Date
July 1 2008
Last Update
May 9 2011
Active Locations (1)
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1
Chu Saint Louis
Paris, France, 75010