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A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax

NCT07148180 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-02-05

No results posted yet for this study

Summary

The purpose of this research study is to test the safety and efficacy of a new drug combination with three agents, azacitidine, venetoclax and tagraxofusp. Leftover (residual) leukemia disease that is not visible by eye can be increase the chance of disease recurrence. This research study is to determine if the combination therapy can safely help to control residual Acute Myeloid Leukemia (AML) and to prevent disease recurrence.

The names of the study drugs involved in this study are:

* Tagraxofusp (a type of CD123-directed cytotoxin)
* Azacitidine (a type of standard of care cytidine nucleoside analog)
* Venetoclax (a type of standard of care BCL-2 inhibitor)

Conditions

Interventions

DRUG

Tagraxofusp

A CD123-directed cytotoxin, Single-use vial, via intravenous (into the vein) infusion per protocol.

DRUG

Azacitidine (AZA)

A cytidine nucleoside analog, single-use vial, via intravenous infusion or subcutaneous (under the skin) injection per standard of care.

DRUG

Venetoclax

A BCL-2 inhibitor, tablet, via orally per standard of care.

Sponsors & Collaborators

  • Stemline Therapeutics, Inc.

    collaborator INDUSTRY

  • Break Through Cancer Foundation

    collaborator UNKNOWN

  • Jacqueline Garcia, MD

    lead OTHER

Principal Investigators

  • Jacqueline Garcia, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-02
Primary Completion
2028-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07148180 on ClinicalTrials.gov