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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00339196 |
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. |
Estimated Enrollment: | 25 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | July 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
de novo AML without previous treatment in elderly patients (FAB-M3 excluded) , if :
Exclusion Criteria:
Contact: Emmanuel RAFFOUX, MD | +33 (0) 1 42 49 96 49 | emmanuel.raffoux@sls.aphp.fr |
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 |
Principal Investigator: | Emmanuel RAFFOUX, MD, | Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | P050202 |
Study First Received: | June 12, 2006 |
Last Updated: | March 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00339196 |
Health Authority: | France: Ministry of Health |
AML MDS High risk Demethylating agents HDAC Inhibitors |
Myelodysplastic syndromes Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Myelodysplasia Acute myelogenous leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute |
Valproic Acid Leukemia Preleukemia Azacitidine Tretinoin Bone Marrow Diseases Acute myelocytic leukemia |
Antimetabolites Neurotransmitter Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Enzyme Inhibitors Antimanic Agents Pharmacologic Actions Keratolytic Agents Neoplasms Therapeutic Uses GABA Agents Dermatologic Agents Central Nervous System Agents Anticonvulsants |