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NCT06456463 | RECRUITING | Acute Myeloid Leukemia

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

Stemline Therapeutics, Inc.

Brief 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.

Condition or disease

Acute Myeloid Leukemia

Intervention/treatment

Tagraxofusp

Venetoclax

Azacitidine

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 76 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase II Multicenter Open-label Trial of Tagraxofusp (Tag) in Combination With Venetoclax and Azacitidine (Ven/Aza) in Adults With Previously Untreated CD123+ Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy
Actual Study Start Date : 2025-01-14
Estimated Primary Completion Date : 2028-02-09
Estimated Study Completion Date : 2030-02-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 confirmed centrally by flow cytometry.
  • * 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 comorbidities
      • * 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 comorbidity that the investigator judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Sponsor.
      • * 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.
          • * Willing and able to receive standard induction therapy.
          • * Treatment for an antecedent hematologic disease with a hypomethylating agent, venetoclax, tagraxofusp, purine analogue, cytarabine, intensive chemotherapy, chimeric antigen receptor-T therapy, or other experimental therapies.
          • * AML with central nervous system involvement.
          • Note: Other inclusion/exclusion criteria may apply.
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy

Location Details

NCT06456463

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

University of California, Los Angeles

Los Angeles, California, United States, 90095

NOT YET RECRUITING

United States, California

Stanford University Medical Center

Palo Alto, California, United States, 94305

NOT YET RECRUITING

United States, Florida

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

RECRUITING

United States, Florida

AdventHealth Cancer Institute

Orlando, Florida, United States, 32804

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute (DFCI)

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

NOT YET RECRUITING

United States, Road cancer

Henry Ford Health

Detroit, Road cancer, United States, 48202

RECRUITING

United States, Missouri

Washington University - Siteman Cancer Center

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, New Jersey

John Theurer Cancer Center - Hackensack Meridian Health

Hackensack, New Jersey, United States, 07601

RECRUITING

United States, New Jersey

Rutgers Cancer Institute

New Brunswick, New Jersey, United States, 08901

NOT YET RECRUITING

United States, New York

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States, 14203

NOT YET RECRUITING

United States, New York

North Shore University Hospital

Manhasset, New York, United States, 11030

RECRUITING

United States, New York

NYU Langone Health

New York, New York, United States, 10016

RECRUITING

United States, New York

Columbia University Irving Medical Center

New York, New York, United States, 10032

RECRUITING

United States, North Carolina

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States, 28204

RECRUITING

United States, North Carolina

Novant Health Derrick L Davis Cancer Center

Winston-Salem, North Carolina, United States, 27103

NOT YET RECRUITING

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

NOT YET RECRUITING

United States, Pennsylvania

Sydney Kimmel (Thomas Jefferson University)

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, Tennessee

Sarah Cannon, the Cancer Institute of HCA Healthcare

Nashville, Tennessee, United States, 37203

NOT YET RECRUITING

United States, Tennessee

Tennessee Oncology

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Baylor Scott & White Health

Dallas, Texas, United States, 75246

RECRUITING

United States, Texas

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

NOT YET RECRUITING

United States, Utah

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84132

NOT YET RECRUITING

United States, Washington

Fred Hutch Cancer Center

Seattle, Washington, United States, 98109

NOT YET RECRUITING

Australia, New South Wales

Concord Repatriation General Hospital

Concord, New South Wales, Australia, 2139

NOT YET RECRUITING

Australia, Queensland

Townsville Hospital

Townsville, Queensland, Australia, 4814

NOT YET RECRUITING

Australia, South Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

NOT YET RECRUITING

Australia, Victoria

Box Hill Hospital

Box Hill, Victoria, Australia, 3128

NOT YET RECRUITING

Australia, Victoria

Monash Medical Centre

Clayton, Victoria, Australia, 3168

RECRUITING

Australia, Victoria

St. Vincents Hospital

Fitzra, Victoria, Australia, 3065

RECRUITING

Australia, Victoria

Austin Hospital

Heidelberg, Victoria, Australia, 3084

NOT YET RECRUITING

Australia, Western Australia

Royal Perth Hospital

Perth, Western Australia, Australia, 6000