Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

181

Participants

Timeline

Start Date

December 6, 2019

Primary Completion Date

October 17, 2023

Study Completion Date

December 31, 2026

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Gilteritinib

"Induction: 120 mg orally daily x 14 days starting on day 8~Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles)"

DRUG

Midostaurin

"Induction: 50 mg orally twice daily x 14 days beginning on day 8~Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles)"

DRUG

Daunorubicin

"First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3~Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3"

DRUG

Cytarabine

"Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1~Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1~Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles"

Trial Locations (44)

10029

Mount Sinai, New York

10065

Memorial Sloan Kettering Cancer Center, New York

Weill Cornell Medicine New York Presbyterian Hospital, New York

11042

Northwell Health, Lake Success

13210

SUNY Upstate Medical University, Syracuse

14642

University of Rochester Medical Center, Rochester

15232

University of Pittsburgh Medical Center, Pittsburgh

17033

Penn State Milton S. Hershey Medical Center, Hershey

17822

Geisinger Medical Center, Danville

19104

University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University, Philadelphia

21287

Johns Hopkins University, Baltimore

26506

West Virginia University, Morgantown

27834

East Carolina University, Greenville

30912

Augusta University Medical Center, Augusta

32224

Mayo Clinic- Jacksonville, FL, Jacksonville

37232

Vanderbilt University, Nashville

40536

University of Kentucky Markey Cancer Center, Lexington

44106

University Hospitals Cleveland Medical Center, Cleveland

45267

University of Cincinnati Medical Center, Cincinnati

46237

Franciscan Health Indianapolis, Indianapolis

48106

St. Joseph's Mercy Hospital, Ann Arbor

53188

UW Cancer Center at ProHealth Care, Waukesha

53226

Medical College of Wisconsin, Milwaukee

53792

University of Wisconsin Clinical Science Center, Madison

54449

Marshfield Medical Center, Marshfield

55905

Mayo Clinic- Rochester, MN, Rochester

60451

University of Chicago Medical Center, Chicago

60611

Northwestern University Feinberg School of Medicine, Chicago

68105

University of Nebraska Medical Center, Omaha

70121

Ochsner Clinic Foundation, New Orleans

73104

University of Oklahoma Stephenson Cancer Center, Oklahoma City

84143

LDS Hospital, Salt Lake City

85258

HonorHealth Research Institute, Scottsdale

90095

UCLA, Los Angeles

92868

UC Irvine Health, Orange

93611

University of California, San Francisco-Fresno (University Oncology Associates), Clovis

94115

Kaiser Permanente Santa Clara, Santa Clara

94611

Kaiser Permanente Oakland, Oakland

95661

Kaiser Permanente Roseville, Roseville

99218

MultiCare, Spokane

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

07962

Atlantic Health Systems/Morristown Medical Center, Morristown

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Astellas Pharma Inc

INDUSTRY

lead

PrECOG, LLC.

OTHER

NCT03836209 - Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter