Study of MEN1112 Intravenous Infusion in Relapsed or Refractory Acute Myeloid Leukemia

PHASE1TerminatedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

April 9, 2021

Study Completion Date

April 9, 2021

Conditions
Recurrent Adult Acute Myeloid LeukemiaAcute Myeloid Leukemia, in Relapse
Interventions
DRUG

MEN1112

"Intravenous infusion of MEN1112 pro/Kg body weight dose will be administered for two 21-day cycles; MEN1112 dose is administered as' one shot infusion' (first group of patients) and as a dose to be infused in 3 days for the first two doses in Cycle 1 (second group of patients).~Two treatment cycles will be followed by a 4-week End of Treatment Period and a Follow-up period. The individual treatment/observation period is six months (except for female patients of childbearing potential that will undergo monthly pregnancy test until 6 months from the last study drug administration)."

Trial Locations (29)

1200

Brussels

2060

Antwerp

4000

Liège

5530

Yvoir

10126

Torino

13273

Marseille

20132

Milan

25123

Brescia

31059

Toulouse

40126

Bologna

44093

Nantes

45147

Essen

46026

Valencia

59037

Lille

60590

Frankfurt

69495

Lyon

81377

Munich

94805

Villejuif

Unknown

Roeselare

Grenoble

Paris

Pierre-Bénite

Dresden

Pamplona

Salamanca

Seville

00133

Rome

08916

Badalona

08035

Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Menarini Group

INDUSTRY

NCT02353143 - Study of MEN1112 Intravenous Infusion in Relapsed or Refractory Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter