A Study of the Efficacy and Safety of Lenalidomide Combined to Escalating Doses of Chemotherapy in Intermediate-2-or High Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) With Del 5q

PHASE2UnknownINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Myelodysplastic SyndromeChronic Myelomonocytic LeukemiaAcute Myeloid Leukemia
Interventions
DRUG

Lenalidomide

"1. Induction treatment Lenalidomide 10 mg once daily PO during 3 weeks . in combination with classical 7+3 chemotherapy.~2. Consolidation treatment 6 monthly courses of : Lenalidomide 10 mg/ d during the first 2 weeks in combination with classical 5+1 consolidation chemotherapy~3. Maintenance treatment Lenalidomide 10 mg/d 2 weeks every month until relapse~In absence of toxicity, 20 additionnal patients will be included with lenalidomide dose of 25mg/J, then 20 other additionnals patients with Lenalidomide 50mg/J"

Trial Locations (25)

13009

Institut Paoli Calmettes, Marseille

26953

CH de Valence, Valence

31059

Hopital Purpan Service d'Hématologie Clinique, Toulouse

32307

Centre Hospitalier de Lens, Lens

33604

CHU Haut-Lévèque, Bordeaux

44093

CHU de nantes, Nantes

54511

CHU Brabois, Nancy

62307

centre hospitalier de Lens, Lens

63058

CHU de Clermont-Ferrand, Clermont-Ferrand

64100

Centre Hospitalier de La Cote Basque, Bayonne

66046

Centre Hospitalier Joffre, Perpignan

67098

Hôpital Hautepierre, Strasbourg

69495

Centre Hospitalier Lyon Sud, Lyon

72037

Centre Hospitalier du Mans, Le Mans

73011

Centre hospitalier de Chambéry, Chambéry

75475

Hoiptal St Louis, Paris

75679

Hopital Cochin-Hematology, Paris

76038

Centre Henri Becquerel, Rouen

87046

Hôpital Limoges, Limoges

94010

Centre henri Mondor, Créteil

94805

Institut gustave Roussy, Villejuif

95107

hopital Victor Dupouy, Argenteuil

49 000

CH Angers, Angers

93 000

Hôpital Avicenne, Bobigny

06202

Hôpital Archet1, Nice

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

Groupe Francophone des Myelodysplasies

OTHER

NCT00885508 - A Study of the Efficacy and Safety of Lenalidomide Combined to Escalating Doses of Chemotherapy in Intermediate-2-or High Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) With Del 5q | Biotech Hunter | Biotech Hunter