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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00339196
First received: June 12, 2006
Last updated: May 6, 2011
Last verified: March 2007
  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
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:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014