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

This study is currently recruiting participants.

Verified by Assistance Publique - Hôpitaux de Paris, March 2007

First Received: June 12, 2006 Last Updated: March 14, 2007 History of Changes

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00339196

Purpose

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 myeloïd leukaemia Hematological response at 6 months Uncontrolled prospective cohort.

Condition	Intervention	Phase
Acute Myelogenous Leukaemia (AML) Myelodysplastic Syndrome (MDS)	Drug: 5 azacytidine - Valproïc acid- Retinoic acid	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Multi Centers, Open-Trial Phase II Study Evaluating 5-Azacytidine (Vidaza®) + Valproic Acid (Depakine ®) Before Administration of Retinoic Acid (Vesanoid®) in Patients With Acute Myelogenous Leukemia and High Risk Myelodysplasia.

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Divalproex sodium Valproic acid Tretinoin Azacitidine Valproate Sodium

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Hematological response at 6 months

Secondary Outcome Measures:

Evaluating Red Blood cells and Platelets transfusion
Evaluating Days of hospitalisation
Evaluating Infectious events

Estimated Enrollment:	25
Study Start Date:	July 2006
Estimated Study Completion Date:	July 2008

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00339196

Contacts

Contact: Emmanuel RAFFOUX, MD

+33 (0) 1 42 49 96 49

emmanuel.raffoux@sls.aphp.fr

Locations

France
Chu Saint Louis	Recruiting
PARIS, France, 75010
Contact: Emmanuel RAFFOUX, MD + 33 (0) 1 42 49 96 49 emmanuel.raffoux@sls.aphp.fr
Principal Investigator: Emmanuel RAFFOUX, MD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Emmanuel RAFFOUX, MD,

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Study ID Numbers:	P050202
Study First Received:	June 12, 2006
Last Updated:	March 14, 2007
ClinicalTrials.gov Identifier:	NCT00339196 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

AML
MDS High risk
Demethylating agents
HDAC Inhibitors

Study placed in the following topic categories:

Antimetabolites
Neurotransmitter Agents
Tranquilizing Agents
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Psychotropic Drugs
Central Nervous System Depressants
Leukemia, Myeloid
Antimanic Agents
Leukemia, Myeloid, Acute

Valproic Acid
Keratolytic Agents
Leukemia
Preleukemia
Acute Myelocytic Leukemia
Acute Myeloid Leukemia, Adult
Azacitidine
Tretinoin
Bone Marrow Diseases
Anticonvulsants

Additional relevant MeSH terms:

Antimetabolites
Neurotransmitter Agents
Antimetabolites, Antineoplastic
Precancerous Conditions
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Psychotropic Drugs
Leukemia, Myeloid, Acute
Valproic Acid
Keratolytic Agents
Leukemia
Preleukemia
Therapeutic Uses
Azacitidine

Dermatologic Agents
Neoplasms by Histologic Type
Tranquilizing Agents
Hematologic Diseases
Myelodysplastic Syndromes
Central Nervous System Depressants
Enzyme Inhibitors
Leukemia, Myeloid
Antimanic Agents
Pharmacologic Actions
Neoplasms
GABA Agents
Tretinoin
Bone Marrow Diseases
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 02, 2009