BridgeMD
New treatment option for Acute Myeloid Leukemia
Official title A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
ClinicalTrials.gov ID: NCT06456463
What this study is testing
What is Tagraxofusp?
Tagraxofusp is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as Tag, Elzonris.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Previously untreated with histological confirmation of AML by World Health Organization 2022 criteria and are ineligible for treatment with a...
- Participant has any level of CD123 expression on blasts.
- Participants 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:
You likely can't join if
- Participant has received prior therapy for AML.
- Participant is willing and able to receive standard induction therapy.
- Participant has received treatment for an antecedent hematologic disease with a hypomethylating agent, venetoclax, tagraxofusp, purine analogue...
- Participant has AML with central nervous system involvement. Note: Other inclusion/exclusion criteria may apply.
See the full eligibility 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...
- Participant has any level of CD123 expression on blasts.
- Participants 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:
- 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 condition for which the physician judges the participant to be unsuitable for intensive chemotherapy.
- 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
- Participant has received prior therapy for AML.
- Participant is willing and able to receive standard induction therapy.
- Participant has received treatment for an antecedent hematologic disease with a hypomethylating agent, venetoclax, tagraxofusp, purine analogue, cytarabine, intensive chemotherapy, SCT, chimeric antigen receptor-T...
- Participant has AML with central nervous system involvement. Note: Other inclusion/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Stanford, California, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- New Brunswick, New Jersey, United States
- Buffalo, New York, United States
- Manhasset, New York, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Stanford, California, United States; Miami, Florida, United States; Orlando, Florida, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.