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

Description

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.

Conditions

Acute Myeloid Leukemia

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Acute Myeloid Leukemia
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California, Los Angeles, Los Angeles, California, United States, 90095

Miami

University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States, 33136

Orlando

AdventHealth Cancer Institute, Orlando, Florida, United States, 32804

Boston

Dana Farber Cancer Institute (DFCI), Boston, Massachusetts, United States, 02114

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Detroit

Henry Ford Health, Detroit, Michigan, United States, 48202

Saint Louis

Washington University - Siteman Cancer Center, Saint Louis, Missouri, United States, 63110

Hackensack

John Theurer Cancer Center - Hackensack Meridian Health, Hackensack, New Jersey, United States, 07601

New Brunswick

Rutgers Cancer Institute, New Brunswick, New Jersey, United States, 08901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Previously untreated with histological confirmation of AML by World Health Organization 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 determined 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%.
  • * Left ventricular ejection fraction ≤50%.
  • * 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 and Medical Monitor prior to enrollment.
  • * ECOG performance status:
  • * Of 0 to 2 for participants if ≥75 years of age, or
  • * Of 0 to 3 for participants ≥18 to 74 years of age.
  • * Participant has received prior therapy for AML.
  • * Willing and able to receive standard induction therapy.
  • * Treatment for an antecedent hematologic disease with any of the following:
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stemline Therapeutics, Inc.,

Study Record Dates

2030-02-11