Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

244

Participants

Timeline

Start Date

June 9, 2014

Primary Completion Date

July 5, 2022

Study Completion Date

July 5, 2022

Conditions
AML
Interventions
BIOLOGICAL

Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off

Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.

BIOLOGICAL

Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off

Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

BIOLOGICAL

Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off

Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

BIOLOGICAL

Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off

Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

BIOLOGICAL

Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose

Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

BIOLOGICAL

Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose

Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.

BIOLOGICAL

Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose

Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

BIOLOGICAL

Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose

Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

BIOLOGICAL

Flotetuzumab 700 ng/kg/day, continuous infusion, after multi-step lead-in dose

Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

DRUG

Ruxolitinib

Oral inhibitor of JAK kinase

BIOLOGICAL

Flotetuzumab 300 ng/kg/day, continuous infusion, after multi-step lead-in dose

Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

Trial Locations (43)

3075

Erasmus University Medical Center, Rotterdam

9713

University Medical Center Groningen, Groningen

11794

Stony Brook Medicine, Stony Brook

13002

Institut Paoli-Calmettes, Marseille

13353

Charité - Universitätsmedizin Berlin, Berlin

20057

Georgetown University - Lombardi Cancer Center, Washington D.C.

20132

University Vita-Salute San Raffaele, Milan

20246

Universitätsklinik Hamburg-Eppendorf, Hamburg

21201

University of Maryland, Baltimore

27599

University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill

27710

Duke University Medical Center, Durham

30322

Emory University, Atlanta

31059

Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse

33612

Moffitt Cancer Center, Tampa

37044

CHRU de Tours - Hôpital Bretonneau, Tours

37232

Vanderbilt-Ingram Cancer Center, Nashville

40138

Policlinico Sant'Orsola Malpighi, Bologna

44093

Centre Hospitalier Universitaire de Nantes, Nantes

44195

Cleveland Clinic, Cleveland

48109

University of Michigan, Ann Arbor

48123

Unità Operativa di Ematologia Ospedale Santa Maria delle Croci, Ravenna

53226

Medical College of Wisconsin, Milwaukee

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz

60153

Loyola University Chicago - Cardinal Bernadin Cancer Center, Maywood

63110

Washington University School of Medicine, St Louis

74014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola

77030

The University of Texas MD Anderson Cancer Center, Houston

81675

III. Med. Klinik-Klinikum rechts der Isar-Technische Universität München, Munich

91010

City of Hope National Medical Center, Duarte

92093

UCSD Moores Cancer Center, La Jolla

94115

UCSF - Helen Diller Family Comprehensive Cancer Center, San Francisco

94143

University of California, San Francisco, San Francisco

97080

Medizinische Klinik und II, Universitätsklinikum Würzburg, Würzbur

97213

Providence Portland Medical Center, Portland

98109

Fred Hutchinson Cancer Research Center, Seattle

01307

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden

04103

Universitätsklinikum Leipzig, Leipzig

Unknown

Rambam Health Care Campus, Haifa

Shaare Zedek Medical Center, Jerusalem

Universitat Autonomaa de Barcelona (UAB) - Hospital de la Santa Creu i de Sant Pau, Barcelona

Hospital Universitario 12 de Octubre, Madrid

King's Health Partners, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MacroGenics

INDUSTRY

NCT02152956 - Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML) | Biotech Hunter | Biotech Hunter