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

Sponsor:	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 MYELOID leukaemia Hematological response at 6 months Uncontrolled prospective cohort.

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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: Acute Myeloid Leukemia Leukemia Myelodysplastic Syndromes

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 [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluating Red Blood cells and Platelets transfusion [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
Evaluating Days of hospitalisation [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
Evaluating Infectious events [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Enrollment:	25
Study Start Date:	July 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 5-azacytidine VALPROIC acid and ATRA	Drug: 5 azacytidine - VALPROIC acid- Retinoic acid 5 azacytidine - VALPROIC acid- Retinoic acid Other Name: 5 azacytidine - VALPROIC acid- Retinoic acid

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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

Locations

France
Chu Saint Louis
Paris, France, 75010

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Emmanuel RAFFOUX, MD,

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Thérèse NGOUE, Department Clinical Research of Decveloppement
ClinicalTrials.gov Identifier:	NCT00339196 History of Changes
Other Study ID Numbers:	P050202
Study First Received:	June 12, 2006
Last Updated:	May 6, 2011
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

AML
MDS High risk
Demethylating agents
HDAC Inhibitors

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Azacitidine
Valproic Acid
Tretinoin
Antimetabolites, Antineoplastic
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Anticonvulsants
Central Nervous System Agents
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Keratolytic Agents

ClinicalTrials.gov processed this record on February 12, 2012