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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00339196
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : May 9, 2011
Information provided by:
Assistance Publique - Hôpitaux de Paris

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 myelodysplasia and acute MYELOID leukaemia Hematological response at 6 months Uncontrolled prospective cohort.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukaemia (AML) Myelodysplastic Syndrome (MDS) Drug: 5 azacytidine - VALPROIC acid- Retinoic acid Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : July 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Arm Intervention/treatment
Experimental: 1
5-azacytidine VALPROIC acid and ATRA
Drug: 5 azacytidine - VALPROIC acid- Retinoic acid
5 azacytidine - VALPROIC acid- Retinoic acid

Primary Outcome Measures :
  1. Hematological response at 6 months [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  1. Evaluating Red Blood cells and Platelets transfusion [ Time Frame: during the study ]
  2. Evaluating Days of hospitalisation [ Time Frame: during the study ]
  3. Evaluating Infectious events [ Time Frame: during the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00339196

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Chu Saint Louis
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Emmanuel RAFFOUX, MD, Assistance Publique - Hôpitaux de Paris
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Responsible Party: Thérèse NGOUE, Department Clinical Research of Decveloppement Identifier: NCT00339196    
Other Study ID Numbers: P050202
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: May 9, 2011
Last Verified: March 2007
Keywords provided by Assistance Publique - Hôpitaux de Paris:
MDS High risk
Demethylating agents
HDAC Inhibitors
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Valproic Acid
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Keratolytic Agents
Dermatologic Agents
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs