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
Jacqueline Garcia, MD
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)
Description
This phase 1/2 study, single-arm, multi-center, open-labeled clinical trial 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. A Phase 1/2 clinical trial tests the safety and effectiveness of an investigational drug combination to learn whether the dru…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years. * History of known diagnosis of Acute Myeloid Leukemia (including de novo, secondary or AML arising from MDS). * Subjects must be in CR, CRi, or CRh with \<5% morphologic blasts in bone marrow * Any evidence of CD123+ by central assessment. * Participants must have measurable disease, defined as ≥ 0.1% by multiparametric flow cytometric assay as assessed by central laboratory * ECOG performance status ≤2 (see Appendix A). * Subjects must have adequate organ and marrow function as defined below: * total bilirubin ≤ 1.5 x institutional upper limit of nor…
Interventions
- DrugTagraxofusp
A CD123-directed cytotoxin, Single-use vial, via intravenous (into the vein) infusion per protocol.
- DrugAzacitidine (AZA)
A cytidine nucleoside analog, single-use vial, via intravenous infusion or subcutaneous (under the skin) injection per standard of care.
- DrugVenetoclax
A BCL-2 inhibitor, tablet, via orally per standard of care.
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts