A Phase II Trial of SGI-110 in Patients With IPSS High and Int 2 Myelodysplastic Syndrome, Acute Myeloid Leukemia With 20-30% Marrow Blasts or Chronic Myelomonocytic Leukemia Type 2 Not Responding to Azacitidine or Decitabine After at Least 6 Courses or Relapsing After a Response

PHASE2CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

August 4, 2014

Primary Completion Date

February 6, 2016

Study Completion Date

April 23, 2018

Conditions
MDS
Interventions
DRUG

SGI-110 administration

"SGI-110 will be administered SC at 60 mg/m²/day x5 consecutive days for each cycle. Cycle duration is 28 days. Patients with Complete Remission (CR), Partial Remission (PR), marrow CR or Hematological Improvement (HI) after 6 Cycles of therapy (IWG 2006 criteria) may continue treatment until progression.~A dose reduction to 45 and even 30 mg/m²/day will be made in case of haematological toxicity. Patients with no response (NR) to treatment will be withdrawn from the protocol after the last treatment Cycle."

Trial Locations (27)

13273

Hôpital Paoli Calmettes, Marseille

14033

CHU Clémenceau, Caen

31059

Chu Purpan, Toulouse

33604

CHU de Haut-Lévèque, Pessac

34000

Clinique Beausoleil (Montpellier), Montpellier

37044

CHU Bretonneau, Tours

38043

CHU de Grenoble, Grenoble

44093

CHU de nantes, Nantes

44277

Centre Catherine de Sienne (Nantes), Nantes

45000

CHR Orléans, Orléans

54511

CHU Brabois, Vandœuvre-lès-Nancy

64100

Centre Hospitalier de La Cote Basque, Bayonne

66046

Centre Hospitalier Joffre, Perpignan

69495

CH Lyon Sud, Lyon

72000

Centre Hospitalier du Mans, Le Mans

74374

Centre Hospitalier de la région d'Annecy, Pringy

75475

Hopital St Louis T4, Paris

76038

Centre Henri Becquerel, Rouen

77100

Centre Hospitalier de Meaux, Meaux

84000

CH Avignon, Avignon

86000

CHU de Poitiers, Poitiers

87046

CHRU Limoges, Limoges

94010

CHU Henri Mondor, Créteil

49 000

CH Angers, Angers

93 000

Hôpital Avicenne, Bobigny

06 202

CHU de Nice - Hopital de l'Archet 1, Nice

Unknown

Hopital Purpan Service d'Hématologie Clinique, Toulouse

Sponsors
All Listed Sponsors
collaborator

Astex Pharmaceuticals, Inc.

INDUSTRY

lead

Groupe Francophone des Myelodysplasies

OTHER