A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy

PHASE2RecruitingINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

January 14, 2025

Primary Completion Date

February 9, 2028

Study Completion Date

February 11, 2030

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Tagraxofusp

Tagraxofusp will be administered by intravenous infusion for 3 consecutive days during each 28-day cycle.

DRUG

Venetoclax

Venetoclax will be administered as an oral tablet (400 milligrams \[mg\]) daily, with ramp up in Cycle 1, and should be continued at target dose (400 mg) for the remainder of Cycle 1 and subsequent cycles of 28 days each.

DRUG

Azacitidine

Azacitidine will be administered subcutaneously or by intravenous infusion (75 milligrams/square meter) over 7 days of each 28-day cycle, per institutional guidelines/physician choice.

Trial Locations (33)

2139

RECRUITING

Concord Repatriation General Hospital, Concord

3065

RECRUITING

St. Vincents Hospital, Fitzroy

3084

RECRUITING

Austin Hospital, Heidelberg

3128

RECRUITING

Box Hill Hospital, Box Hill

3168

RECRUITING

Monash Medical Centre, Clayton

4814

NOT_YET_RECRUITING

Townsville Hospital, Townsville

5000

RECRUITING

Royal Adelaide Hospital, Adelaide

6000

NOT_YET_RECRUITING

Royal Perth Hospital, Perth

10016

RECRUITING

NYU Langone Health, New York

10032

RECRUITING

Columbia University Irving Medical Center, New York

11030

NOT_YET_RECRUITING

North Shore University Hospital, Manhasset

14203

NOT_YET_RECRUITING

Roswell Park Comprehensive Cancer Center, Buffalo

19107

NOT_YET_RECRUITING

Sydney Kimmel (Thomas Jefferson University), Philadelphia

27103

RECRUITING

Novant Health Derrick L Davis Cancer Center, Winston-Salem

28204

RECRUITING

Novant Health Presbyterian Medical Center, Charlotte

32804

RECRUITING

AdventHealth Cancer Institute, Orlando

33136

RECRUITING

University of Miami, Miami

37203

RECRUITING

Sarah Cannon, the Cancer Institute of HCA Healthcare, Nashville

RECRUITING

Tennessee Oncology, Nashville

44195

NOT_YET_RECRUITING

Cleveland Clinic Foundation, Cleveland

48202

NOT_YET_RECRUITING

Henry Ford Health, Detroit

60637

NOT_YET_RECRUITING

University of Chicago, Chicago

63110

RECRUITING

Washington University - Siteman Cancer Center, St Louis

75246

RECRUITING

Baylor Scott & White Health, Dallas

77030

RECRUITING

University of Texas MD Anderson Cancer Center, Houston

84132

NOT_YET_RECRUITING

Huntsman Cancer Institute, Salt Lake City

90095

RECRUITING

University of California, Los Angeles, Los Angeles

94305

NOT_YET_RECRUITING

Stanford University Medical Center, Palo Alto

02114

RECRUITING

Dana Farber Cancer Institute (DFCI), Boston

RECRUITING

Massachusetts General Hospital, Boston

02215

RECRUITING

Beth Israel Deaconess Medical Center, Boston

07601

RECRUITING

John Theurer Cancer Center - Hackensack Meridian Health, Hackensack

08901

RECRUITING

Rutgers Cancer Institute, New Brunswick

All Listed Sponsors
lead

Stemline Therapeutics, Inc.

INDUSTRY