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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00339196
First Posted: June 20, 2006
Last Update Posted: May 9, 2011
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.
Information provided by:
Assistance Publique - Hôpitaux de Paris
  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 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


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

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

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

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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Thérèse NGOUE, Department Clinical Research of Decveloppement
ClinicalTrials.gov Identifier: NCT00339196     History of Changes
Other Study ID Numbers: P050202
First Submitted: June 12, 2006
First Posted: June 20, 2006
Last Update Posted: May 9, 2011
Last Verified: March 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
AML
MDS High risk
Demethylating agents
HDAC Inhibitors

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Azacitidine
Valproic Acid
Tretinoin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Anticonvulsants
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Keratolytic Agents
Dermatologic Agents