Acute Myeloid LeukemiaPhase 2TRILLIUMNCT06456463
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
A Phase 2 study testing Tagraxofusp, Venetoclax and Azacitidine in people with Acute Myeloid Leukemia, run by Stemline Therapeutics, Inc. at 32 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Tagraxofusp, Venetoclax and Azacitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 14 Jan 2025to 11 Feb 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 comorbidity.
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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 therapy, or other experimental therapies.
- Participant has AML with central nervous system involvement.
- Note: Other inclusion/exclusion criteria may apply.
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States24 sites
Dana Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02114
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14203
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Baylor Scott & White Health
Dallas, Texas, 75246
Henry Ford Health System Brigitte Harris Cancer Pavillion
Detroit, Michigan, 48202
John Theurer Cancer Center - Hackensack Meridian Health
Hackensack, New Jersey, 07601
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of California, Los Angeles
Los Angeles, California, 90095
North Shore University Hospital
Manhasset, New York, 11030
University of Miami
Miami, Florida, 33136
Sarah Cannon, the Cancer Institute of HCA Healthcare
Nashville, Tennessee, 37203
Tennessee Oncology
Nashville, Tennessee, 37203
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
NYU Langone Health
New York, New York, 10016
Columbia University Irving Medical Center
New York, New York, 10032
AdventHealth Cancer Institute
Orlando, Florida, 32804
Sydney Kimmel (Thomas Jefferson University)
Philadelphia, Pennsylvania, 19107
Washington University - Siteman Cancer Center
St Louis, Missouri, 63110
Stanford Health Care
Stanford, California, 94305
Novant Health Derrick L Davis Cancer Center
Winston-Salem, North Carolina, 27103
Australia8 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Box Hill Hospital
Box Hill, Victoria, 3128
Monash Medical Centre
Clayton, Victoria, 3168
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Townsville Hospital
Douglas, Queensland, 4814
St. Vincents Hospital
Fitzroy, Victoria, 3065
Austin Hospital
Heidelberg, Victoria, 3084
Royal Perth Hospital
Perth, Western Australia, 6000
About this study
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
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
- Being tested
- Tagraxofusp, Venetoclax, Azacitidine
- Keywords
- CD123+, Tagraxofusp, Venetoclax, Azacitidine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TagraxofuspDrug
Also called Tag, Elzonris
Tagraxofusp will be administered by intravenous infusion for 3 consecutive days during each 28-day cycle.
VenetoclaxDrug
Also called Ven, Venclexta
Venetoclax will be administered as an oral tablet (400 milligrams [mg]) daily, with ramp up in Cycle 1, and should be continued at target dose (400 mg) for the remainder of Cycle 1 and subsequent cycles of 28 days each.
AzacitidineDrug
Also called Aza, Vidaza
Azacitidine will be administered subcutaneously or by intravenous infusion (75 milligrams/square meter) over 7 days of each 28-day cycle, per institutional guidelines/physician choice.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Tagraxofusp (9 μg/kg/day) | Experimental | Participants will receive tagraxofusp in combination with venetoclax and azacitidine. Receives: Drug: Tagraxofusp; Drug: Venetoclax; Drug: Azacitidine |
| Part 1 - Tagraxofusp (12 μg/kg/day) | Experimental | Participants will receive tagraxofusp in combination with venetoclax and azacitidine. Receives: Drug: Tagraxofusp; Drug: Venetoclax; Drug: Azacitidine |
| Part 2 - Tagraxofusp (Selected Dose) and TP53 Wild Type | Experimental | Participants (TP53 wild type) will receive tagraxofusp in combination with venetoclax and azacitidine. Receives: Drug: Tagraxofusp; Drug: Venetoclax; Drug: Azacitidine |
| Part 2 - Tagraxofusp (Selected Dose) and TP53 Mutated | Experimental | Participants (TP53 mutated) will receive tagraxofusp in combination with venetoclax and azacitidine. Receives: Drug: Tagraxofusp; Drug: Venetoclax; Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Determination of Part 2 Selected Dose of Tagraxofusp When Administered in Combination with Venetoclax and Azacitidine
Measured: Cycles 1-4 (up to 112 days; 28 days/cycle)
Part 2: Number of Participants Achieving a Best Overall Response (BOR) of Complete Remission (CR)
Measured: Cycles 1-4 (up to 112 days; 28 days/cycle)
Secondary outcomes (19)
Parts 1 and 2: Number of Participants Achieving a BOR of CR
Measured: Cycles 1-6 (up to 168 days; 28 days/cycle)
Parts 1 and 2: Time to First CR
The time to first CR will be defined as the time from randomization (Cycle 1, Day 1) to the date of first documented CR.
Measured: Cycles 1-6 (up to 168 days; 28 days/cycle)
Parts 1 and 2: Duration of Response
Measured: Cycles 1-6 (up to 168 days; 28 days/cycle)
Parts 1 and 2: Number of Participants Achieving a BOR of CR, CR with Incomplete Hematologic Recovery (CRi), or CR with Partial Hematologic Recovery (CRh)
Measured: Cycles 1-4 (up to 112 days; 28 days/cycle)
Parts 1 and 2: Time to First Composite CR
The time to first composite CR will be defined as the time from randomization (Cycle 1, Day 1) to the date of first documented CR, CRi, or CRh.
Measured: Cycles 1-4 (up to 112 days; 28 days/cycle)
Parts 1 and 2: Number of Participants Achieving a BOR of CR or CRi
Measured: Cycles 1-6 (up to 168 days; 28 days/cycle)
Parts 1 and 2: Time to first CR/CRi
The time to first CR/CRi will be defined as the time from randomization (Cycle 1, Day 1) to the date of first documented CR or CRi.
Measured: Cycles 1-6 (up to 168 days; 28 days/cycle)
Parts 1 and 2: Event-free Survival (EFS)
EFS will be defined as the time from the date of randomization (Cycle 1, Day 1) until the date of treatment failure, hematologic relapse after CR/CRi/CRh, or death from any cause, whichever occurs first.
Measured: Up to approximately 6 years
Parts 1 and 2: CR with Minimal Residual Disease (MRD) Negative
Defined as the number of participants with a presence of marrow MRD of less than 0.01% at the time of CR.
Measured: Cycles 1-6 (up to 168 days; 28 days/cycle)
Parts 1 and 2: Number of Participants Who Bridged to Stem Cell Transplant (SCT) Through Study Treatment
Measured: Up to approximately 6 years
Part 1: Plasma Concentration of Free Tagraxofusp, Venetoclax, and Azacitidine
Measured: Predose, up to 8 hours post dose (Days 4, 5, 6, 7, 14; Cycles 1-4; 28 days/cycle)
Part 2: Plasma Concentration of Free Tagraxofusp and Venetoclax
Measured: Predose, up to 8 hours post dose (Days 4, 5, 6, 7, 14; Cycles 1-4; 28 days/cycle)
Parts 1 and 2: Number of Participants With Serum Anti-drug Antibodies for Tagraxofusp, Venetoclax, and Azacitidine
Measured: Day 4 of each cycle (each cycle is 28 days) up to the end of study (approximately 6 years)
Parts 1 and 2: Exposure-response of Free Tagraxofusp When Administered in Combination with Venetoclax and Azacitidine
The exposure-response relationship will be assessed utilizing the CR rate/composite CR rate and the number of participants experiencing adverse events of interest. This model-based analysis will be conducted to compare the exposure and response of free tagraxofusp, venetoclax, and azacitidine with venetoclax and azacitidine. Results will be reported as percent probability, wherein changes in the percent probability would indicate corresponding changes in the response rates with changes in exposure.
Measured: Up to approximately 6 years
Parts 1 and 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to approximately 6 years
Parts 1 and 2: Overall Survival
Measured: Up to approximately 6 years
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Tagraxofusp and Venetoclax
Measured: Predose, up to 8 hours post dose (Days 4, 5, 6, 7, 14; Cycles 1-4; 28 days/cycle)
Parts 1 and 2: Time to Reach Cmax (Tmax) of Tagraxofusp and Venetoclax
Measured: Predose, up to 8 hours post dose (Days 4, 5, 6, 7, 14; Cycles 1-4; 28 days/cycle)
Parts 1 and 2: Area Under the Concentration-time Curve (AUC) of Tagraxofusp and Venetoclax
Measured: Predose, up to 8 hours post dose (Days 4, 5, 6, 7, 14; Cycles 1-4; 28 days/cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start14 Jan 2025
- Primary completion9 Feb 2028 (estimated)
- Study completion11 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Stemline Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1 (randomized) will evaluate 2 dose levels of tagraxofusp in parallel. The decision to proceed to Part 2 (non-randomized) will be based upon review of cumulative data from Part 1.
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stemline Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456463
- Sponsor's protocol ID
- STML-401-0423
- Other IDs
- U1111-1290-9087, 2024-514660-48
- Acronym
- TRILLIUM
- Status last verified
- Aug 2026
- First submitted
- 31 May 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06456463
- Acronym / sponsor ID
- TRILLIUM / STML-401-0423
- Conditions
- Acute Myeloid Leukemia
- Keywords
- CD123+, Tagraxofusp, Venetoclax, Azacitidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Stemline Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 9 Feb 2028 (estimated)
- Study completion
- 11 Feb 2030 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Part 1 (randomized) will evaluate 2 dose levels of tagraxofusp in parallel. The decision to proceed to Part 2 (non-randomized) will be based upon review of cumulative data from Part 1.
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Tagraxofusp (9 μg/kg/day) | Experimental | Drug: Tagraxofusp, Drug: Venetoclax, Drug: AzacitidineParticipants will receive tagraxofusp in combination with venetoclax and azacitidine. |
| Part 1 - Tagraxofusp (12 μg/kg/day) | Experimental | Drug: Tagraxofusp, Drug: Venetoclax, Drug: AzacitidineParticipants will receive tagraxofusp in combination with venetoclax and azacitidine. |
| Part 2 - Tagraxofusp (Selected Dose) and TP53 Wild Type | Experimental | Drug: Tagraxofusp, Drug: Venetoclax, Drug: AzacitidineParticipants (TP53 wild type) will receive tagraxofusp in combination with venetoclax and azacitidine. |
| Part 2 - Tagraxofusp (Selected Dose) and TP53 Mutated | Experimental | Drug: Tagraxofusp, Drug: Venetoclax, Drug: AzacitidineParticipants (TP53 mutated) will receive tagraxofusp in combination with venetoclax and azacitidine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 comorbidity.
- Participant has any level of CD123 expression on blasts.
- Participants must be considered ineligible for intensive chemotherapy, defined by the following:
- ECOG performance status:
Key exclusion criteria (5 listed)
- 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 therapy, or other experimental therapies.
- Participant has AML with central nervous system involvement.
- Note: Other inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TagraxofuspAlso: Tag, ElzonrisTagraxofusp will be administered by intravenous infusion for 3 consecutive days during each 28-day cycle. | Drug | Part 1 - Tagraxofusp (12 μg/kg/day), Part 1 - Tagraxofusp (9 μg/kg/day), Part 2 - Tagraxofusp (Selected Dose) and TP53 Mutated, Part 2 - Tagraxofusp (Selected Dose) and TP53 Wild Type |
| VenetoclaxAlso: Ven, VenclextaVenetoclax will be administered as an oral tablet (400 milligrams [mg]) daily, with ramp up in Cycle 1, and should be continued at target dose (400 mg) for the remainder of Cycle 1 and subsequent cycles of 28 days each. | Drug | Part 1 - Tagraxofusp (12 μg/kg/day), Part 1 - Tagraxofusp (9 μg/kg/day), Part 2 - Tagraxofusp (Selected Dose) and TP53 Mutated, Part 2 - Tagraxofusp (Selected Dose) and TP53 Wild Type |
| AzacitidineAlso: Aza, VidazaAzacitidine will be administered subcutaneously or by intravenous infusion (75 milligrams/square meter) over 7 days of each 28-day cycle, per institutional guidelines/physician choice. | Drug | Part 1 - Tagraxofusp (12 μg/kg/day), Part 1 - Tagraxofusp (9 μg/kg/day), Part 2 - Tagraxofusp (Selected Dose) and TP53 Mutated, Part 2 - Tagraxofusp (Selected Dose) and TP53 Wild Type |
Primary outcome
Part 1: Determination of Part 2 Selected Dose of Tagraxofusp When Administered in Combination with Venetoclax and Azacitidine
Time frame: Cycles 1-4 (up to 112 days; 28 days/cycle)
Part 2: Number of Participants Achieving a Best Overall Response (BOR) of Complete Remission (CR)
Time frame: Cycles 1-4 (up to 112 days; 28 days/cycle)
19 secondary outcomes
Parts 1 and 2: Number of Participants Achieving a BOR of CR
Time frame: Cycles 1-6 (up to 168 days; 28 days/cycle)
Parts 1 and 2: Time to First CR
Time frame: Cycles 1-6 (up to 168 days; 28 days/cycle)
Parts 1 and 2: Duration of Response
Time frame: Cycles 1-6 (up to 168 days; 28 days/cycle)
Parts 1 and 2: Number of Participants Achieving a BOR of CR, CR with Incomplete Hematologic Recovery (CRi), or CR with Partial Hematologic Recovery (CRh)
Time frame: Cycles 1-4 (up to 112 days; 28 days/cycle)
Parts 1 and 2: Time to First Composite CR
Time frame: Cycles 1-4 (up to 112 days; 28 days/cycle)
Parts 1 and 2: Number of Participants Achieving a BOR of CR or CRi
Time frame: Cycles 1-6 (up to 168 days; 28 days/cycle)
Parts 1 and 2: Time to first CR/CRi
Time frame: Cycles 1-6 (up to 168 days; 28 days/cycle)
Parts 1 and 2: Event-free Survival (EFS)
Time frame: Up to approximately 6 years
Parts 1 and 2: CR with Minimal Residual Disease (MRD) Negative
Time frame: Cycles 1-6 (up to 168 days; 28 days/cycle)
Parts 1 and 2: Number of Participants Who Bridged to Stem Cell Transplant (SCT) Through Study Treatment
Time frame: Up to approximately 6 years
Part 1: Plasma Concentration of Free Tagraxofusp, Venetoclax, and Azacitidine
Time frame: Predose, up to 8 hours post dose (Days 4, 5, 6, 7, 14; Cycles 1-4; 28 days/cycle)
Part 2: Plasma Concentration of Free Tagraxofusp and Venetoclax
Time frame: Predose, up to 8 hours post dose (Days 4, 5, 6, 7, 14; Cycles 1-4; 28 days/cycle)
Parts 1 and 2: Number of Participants With Serum Anti-drug Antibodies for Tagraxofusp, Venetoclax, and Azacitidine
Time frame: Day 4 of each cycle (each cycle is 28 days) up to the end of study (approximately 6 years)
Parts 1 and 2: Exposure-response of Free Tagraxofusp When Administered in Combination with Venetoclax and Azacitidine
Time frame: Up to approximately 6 years
Parts 1 and 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to approximately 6 years
Parts 1 and 2: Overall Survival
Time frame: Up to approximately 6 years
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Tagraxofusp and Venetoclax
Time frame: Predose, up to 8 hours post dose (Days 4, 5, 6, 7, 14; Cycles 1-4; 28 days/cycle)
Parts 1 and 2: Time to Reach Cmax (Tmax) of Tagraxofusp and Venetoclax
Time frame: Predose, up to 8 hours post dose (Days 4, 5, 6, 7, 14; Cycles 1-4; 28 days/cycle)
Parts 1 and 2: Area Under the Concentration-time Curve (AUC) of Tagraxofusp and Venetoclax
Time frame: Predose, up to 8 hours post dose (Days 4, 5, 6, 7, 14; Cycles 1-4; 28 days/cycle)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tagraxofusp, Venetoclax and Azacitidine in people with Acute Myeloid Leukemia, run by Stemline Therapeutics, Inc. at 32 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Determination of Part 2 Selected Dose of Tagraxofusp When Administered in Combination with Venetoclax and Azacitidine (time frame: Cycles 1-4 (up to 112 days; 28 days/cycle)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.