Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes

PHASE1/PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 31, 2011

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Myelodysplastic Syndromes
Interventions
DRUG

Ceplene®, IL-2, Azacitidine

Azacitidine: 75 mg/m2 subcutaneously daily for 7 days every 4 weeks. Ceplene® / IL2: Patients will receive Ceplene at 0.5 mg subcutaneous twice daily and human recombinant IL-2 at 16 400 U/kg subcutaneous twice daily during 15 days for up to 10 cycles, on days 8 to 21 of AZA cycles.

DRUG

Azacitidine

Azacitidine 75 mg/m2 subcutaneously daily for 7 days every 4 weeks

Trial Locations (28)

13273

Hôpital Paoli-Calmettes, Marseille

14033

CHU de Caen, Caen

37044

Hopital Bretonneau, Tours

38043

CHU Grenoble, Grenoble

43033

CHU Angers, Angers

44093

Hematology Dpt, Hopital de l'Hotel Dieu, Nantes

51092

CHRU de Reims, Reims

59020

Hôpital Saint Vincent, Lille

59057

CHRU Hurriez, Lille

63058

CHU de, Clermont-Ferrand

64100

Hôpital de la Côte Basque, Bayonne

66046

Centre Hospitalier Joffre, Perpignan

67098

Centre Hospitalier Universitaire de STRASBOURG, Strasbourg

69437

Hôpital Edouard Heriot, dpt Hématologie Clinique, Lyon

75475

Hopital Saint Louis, Paris

75571

Hôpital Saint Antoine, Paris

75679

CHU Cochin, Paris

76038

Centre Henri Bequerel, Rouen

78157

Hôpital Versailles, Le Chesnay

80054

CHU d'Amiens, Amiens

84000

CH d'Avignon, Avignon

86021

Hôpital Jean-Bernard, Poitiers

87046

CHRU Limoges, Limoges

91106

Centre Hospitalier Sud-Francilien, Corbeil-Essonnes

93009

Hopital Avicenne, Bobigny

94275

CHU de Bicêtre, Le Kremlin-Bicêtre

06202

CHU Archet, Nice

Unknown

Hopital Purpan Service d'Hématologie Clinique, Toulouse

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

EpiCept Corporation

INDUSTRY

lead

Groupe Francophone des Myelodysplasies

OTHER

NCT01324960 - Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes | Biotech Hunter | Biotech Hunter