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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Stemline Therapeutics, Inc.
Study ID
NCT06456463
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tagraxofusp — DRUG
    Tagraxofusp will be administered by intravenous infusion for 3 consecutive days during each 28-day cycle.
  • Venetoclax — DRUG
    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.
  • Azacitidine — DRUG
    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.

Study Details

This study will be divided into 2 parts (Part 1 and Part 2). Part 1 will evaluate 2 doses of tagraxofusp (9 and 12 micrograms/kilogram/day \[μg/kg/day\]), used in combination with venetoclax and azacitidine, to determine the dose for Part 2. This determined dose, in combination with venetoclax and azacitidine, will then be further evaluated in Part 2 in 2 cohorts (TP53 mutated and TP53 wild type). Both parts will be conducted in participants with previously untreated CD123+ AML who are ineligible for intensive chemotherapy.

Key Dates

Start date
Jan 14, 2025
Status verified
Mar 2026
Primary completion
Feb 9, 2028
Completion
Feb 11, 2030

Study Design

Enrollment
83 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 - Tagraxofusp (9 μg/kg/day)
    Participants will receive tagraxofusp in combination with venetoclax and azacitidine.
  • Experimental: Part 1 - Tagraxofusp (12 μg/kg/day)
    Participants will receive tagraxofusp in combination with venetoclax and azacitidine.
  • Experimental: Part 2 - Tagraxofusp (Selected Dose) and TP53 Wild Type
    Participants (TP53 wild type) will receive tagraxofusp in combination with venetoclax and azacitidine.
  • Experimental: Part 2 - Tagraxofusp (Selected Dose) and TP53 Mutated
    Participants (TP53 mutated) will receive tagraxofusp in combination with venetoclax and azacitidine.

Primary Outcome Measure

Part 1: Determination of Part 2 Selected Dose of Tagraxofusp When Administered in Combination with Venetoclax and Azacitidine [ Time Frame: Cycles 1-4 (up to 112 days; 28 days/cycle) ]

Central Contacts

Locations (24)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095
Gary Schiller, MD (PRINCIPAL_INVESTIGATOR)
Stanford Health CareStanfordCalifornia94305
Gabriel Mannis, MD (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Namrata Chandhok, MD (PRINCIPAL_INVESTIGATOR)
AdventHealth Cancer InstituteOrlandoFlorida32804
Shahram Mori, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Anand Patel, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Malgorzata McMasters, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer Institute (DFCI)BostonMassachusetts02114
Andrew A Lane, MD, PhD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Amir Fathi, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Health System Brigitte Harris Cancer PavillionDetroitMichigan48202
Christopher A Willner II, DO (PRINCIPAL_INVESTIGATOR)
Washington University - Siteman Cancer CenterSt LouisMissouri63110
Geoffrey L Uy, MD (PRINCIPAL_INVESTIGATOR)
John Theurer Cancer Center - Hackensack Meridian HealthHackensackNew Jersey07601
James K McCloskey, MD (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer InstituteNew BrunswickNew Jersey08901
Neil D Palmisiano, MD, MS (PRINCIPAL_INVESTIGATOR)
Roswell Park Cancer InstituteBuffaloNew York14203
Eunice S Wang, MD (PRINCIPAL_INVESTIGATOR)
North Shore University HospitalManhassetNew York11030
David Chitty, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical CenterNew YorkNew York10032
Sunil Iyer, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Jun H Choi, MD (PRINCIPAL_INVESTIGATOR)
Novant Health Presbyterian Medical CenterCharlotteNorth Carolina28204
Abhishek Chilkulwar, MD (PRINCIPAL_INVESTIGATOR)
Novant Health Derrick L Davis Cancer CenterWinston-SalemNorth Carolina27103
Abhishek Chilkulwar, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FoundationClevelandOhio44195
Akriti Jain, MD (PRINCIPAL_INVESTIGATOR)
Sydney Kimmel (Thomas Jefferson University)PhiladelphiaPennsylvania19107
Gina Keiffer, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon, the Cancer Institute of HCA HealthcareNashvilleTennessee37203
Stephen A Strickland, MD (PRINCIPAL_INVESTIGATOR)
Tennessee OncologyNashvilleTennessee37203
Jonathan Abbas, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White HealthDallasTexas75246
Bradley W Christensen, MD (PRINCIPAL_INVESTIGATOR)
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Naval G Daver, MD (PRINCIPAL_INVESTIGATOR)

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