Back to Trials
NCT06456463PHASE2Recruiting

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

Stemline Therapeutics, Inc.

Start Date

1/14/2025

Completion Date

2/11/2030

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * Previously untreated with histological confirmation of AML by World Health Organization 2022 criteria and are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, or comorbidity. * Participant has any level of CD123 expression on blasts. * Participants must be considered ineligible for intensive chemotherapy, defined by the following: * ≥75 years of age; or * ≥18 to 74 years of age with at least 1 of the following: * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3. * Diffusing capacity of the lung for carbon monoxide of ≤65% or forced expiratory volume in 1 second ≤65%. * Baseline creatinine clearance ≥30 to \<45 milliliters/minute calculated by the Cockcroft Gault formula or measured by 24-hour urine collection. * Hepatic disorder with total bilirubin \>1.5 x upper limit of normal. * Any other condition for which the physician judges the participant to be unsuitable for intensive chemotherapy. * ECOG performance status: * 0 to 2 for participants ≥75 years of age, or * 0 to 3 for participants ≥18 to 74 years of age. Key Exclusion Criteria: * Participant has received prior therapy for AML. * Participant is willing and able to receive standard induction therapy. * Participant has received treatment for an antecedent hematologic disease with a hypomethylating agent, venetoclax, tagraxofusp, purine analogue, cytarabine, intensive chemotherapy, SCT, chimeric antigen receptor-T therapy, or other experimental therapies. * Participant has AML with central nervous system involvement. Note: Other inclusion/exclusion criteria may apply.

Interventions

DRUG

Tagraxofusp

DRUG

Venetoclax

DRUG

Azacitidine

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Acute Myeloid Leukemia

Locations

University of California, Los Angeles

Los Angeles, California 90095

United States

Stanford Health Care

Stanford, California 94305

United States

University of Miami

Miami, Florida 33136

United States

AdventHealth Cancer Institute

Orlando, Florida 32804

United States

University of Chicago

Chicago, Illinois 60637

United States

Dana Farber Cancer Institute (DFCI)

Boston, Massachusetts 02114

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Henry Ford Health System Brigitte Harris Cancer Pavillion

Detroit, Michigan 48202

United States

Washington University - Siteman Cancer Center

St Louis, Missouri 63110

United States

John Theurer Cancer Center - Hackensack Meridian Health

Hackensack, New Jersey 07601

United States

Rutgers Cancer Institute

New Brunswick, New Jersey 08901

United States

Roswell Park Cancer Institute

Buffalo, New York 14203

United States

North Shore University Hospital

Manhasset, New York 11030

United States

NYU Langone Health

New York, New York 10016

United States

Columbia University Irving Medical Center

New York, New York 10032

United States

Novant Health Presbyterian Medical Center

Charlotte, North Carolina 28204

United States

Novant Health Derrick L Davis Cancer Center

Winston-Salem, North Carolina 27103

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

Sydney Kimmel (Thomas Jefferson University)

Philadelphia, Pennsylvania 19107

United States

Sarah Cannon, the Cancer Institute of HCA Healthcare

Nashville, Tennessee 37203

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

Baylor Scott & White Health

Dallas, Texas 75246

United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Concord Repatriation General Hospital

Concord, New South Wales 2139

Australia

Townsville Hospital

Douglas, Queensland 4814

Australia

Royal Adelaide Hospital

Adelaide, South Australia 5000

Australia

Box Hill Hospital

Box Hill, Victoria 3128

Australia

Monash Medical Centre

Clayton, Victoria 3168

Australia

St. Vincents Hospital

Fitzroy, Victoria 3065

Australia

Austin Hospital

Heidelberg, Victoria 3084

Australia

Royal Perth Hospital

Perth, Western Australia 6000

Australia