RECRUITING

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

Conditions

Acute Myeloid Leukemia CD123+Tagraxofusp Venetoclax Azacitidine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-12

Study Completion:2030-02-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06456463

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Stemline Trials

CONTACT

1-877-332-7961

clinicaltrials@menarinistemline.com

Study Locations (Sites)

University of California, Los Angeles

Los Angeles, California, 90095

United States

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

United States

AdventHealth Cancer Institute

Orlando, Florida, 32804

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

Detroit, Michigan, 48202

United States

Washington University - Siteman Cancer Center

Saint 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 Comprehensive Cancer Center

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

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

Huntsman Cancer Institute

Salt Lake City, Utah, 84132

United States

Collaborators and Investigators

Sponsor: Stemline Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12

Study Completion Date2030-02-11

Study Record Updates

Study Start Date2024-12

Study Completion Date2030-02-11

Terms related to this study

Keywords Provided by Researchers

CD123+
Tagraxofusp
Venetoclax
Azacitidine

Additional Relevant MeSH Terms

Acute Myeloid Leukemia