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

March 5, 2026 updated by: Stemline Therapeutics, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Recruiting
        • Concord Repatriation General Hospital
        • Principal Investigator:
          • Robin Gasiorowski, MBBS
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • Recruiting
        • Townsville Hospital
        • Principal Investigator:
          • Rachael Boles, MD
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Principal Investigator:
          • Devendra Hiwase, MBBS
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Box Hill Hospital
        • Principal Investigator:
          • Stephen Ting, MBBS
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Medical Centre
        • Principal Investigator:
          • Ashvind Prabahran, MD
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • St. Vincents Hospital
        • Principal Investigator:
          • Shuh Ying Tan, MBBS
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Hospital
        • Principal Investigator:
          • Chun Yew Fong, MBBS, PhD
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Recruiting
        • Royal Perth Hospital
        • Principal Investigator:
          • Hun Chuah, MBBS, PhD
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles
        • Principal Investigator:
          • Gary Schiller, MD
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Health Care
        • Principal Investigator:
          • Gabriel Mannis, MD
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Namrata Chandhok, MD
      • Orlando, Florida, United States, 32804
        • Recruiting
        • AdventHealth Cancer Institute
        • Principal Investigator:
          • Shahram Mori, MD, PhD
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Principal Investigator:
          • Anand Patel, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Amir Fathi, MD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Malgorzata McMasters, MD
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Dana Farber Cancer Institute (DFCI)
        • Principal Investigator:
          • Andrew A Lane, MD, PhD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System Brigitte Harris Cancer Pavillion
        • Principal Investigator:
          • Christopher A Willner II, DO
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University - Siteman Cancer Center
        • Principal Investigator:
          • Geoffrey L Uy, MD
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center - Hackensack Meridian Health
        • Principal Investigator:
          • James K McCloskey, MD
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute
        • Principal Investigator:
          • Neil D Palmisiano, MD, MS
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Roswell Park Cancer Institute
        • Principal Investigator:
          • Eunice S Wang, MD
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore University Hospital
        • Principal Investigator:
          • David Chitty, MD
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Principal Investigator:
          • Jun H Choi, MD
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Principal Investigator:
          • Sunil Iyer, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Presbyterian Medical Center
        • Principal Investigator:
          • Abhishek Chilkulwar, MD
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Novant Health Derrick L Davis Cancer Center
        • Principal Investigator:
          • Abhishek Chilkulwar, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Principal Investigator:
          • Akriti Jain, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Sydney Kimmel (Thomas Jefferson University)
        • Principal Investigator:
          • Gina Keiffer, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology
        • Principal Investigator:
          • Jonathan Abbas, MD
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon, the Cancer Institute of HCA Healthcare
        • Principal Investigator:
          • Stephen A Strickland, MD
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor Scott & White Health
        • Principal Investigator:
          • Bradley W Christensen, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Principal Investigator:
          • Naval G Daver, MD

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion 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 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.
      • 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 Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1 - Tagraxofusp (9 μg/kg/day)
Participants will receive tagraxofusp in combination with venetoclax and azacitidine.
Drug: Azacitidine
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.
Other Names:
  • Vidaza
  • Aza
Drug: Tagraxofusp
Tagraxofusp will be administered by intravenous infusion for 3 consecutive days during each 28-day cycle.
Other Names:
  • Elzonris
  • Tag
Drug: Venetoclax
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.
Other Names:
  • Venclexta
  • Ven
Experimental: Part 1 - Tagraxofusp (12 μg/kg/day)
Participants will receive tagraxofusp in combination with venetoclax and azacitidine.
Drug: Azacitidine
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.
Other Names:
  • Vidaza
  • Aza
Drug: Tagraxofusp
Tagraxofusp will be administered by intravenous infusion for 3 consecutive days during each 28-day cycle.
Other Names:
  • Elzonris
  • Tag
Drug: Venetoclax
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.
Other Names:
  • Venclexta
  • Ven
Experimental: Part 2 - Tagraxofusp (Selected Dose) and TP53 Wild Type
Participants (TP53 wild type) will receive tagraxofusp in combination with venetoclax and azacitidine.
Drug: Azacitidine
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.
Other Names:
  • Vidaza
  • Aza
Drug: Tagraxofusp
Tagraxofusp will be administered by intravenous infusion for 3 consecutive days during each 28-day cycle.
Other Names:
  • Elzonris
  • Tag
Drug: Venetoclax
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.
Other Names:
  • Venclexta
  • Ven
Experimental: Part 2 - Tagraxofusp (Selected Dose) and TP53 Mutated
Participants (TP53 mutated) will receive tagraxofusp in combination with venetoclax and azacitidine.
Drug: Azacitidine
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.
Other Names:
  • Vidaza
  • Aza
Drug: Tagraxofusp
Tagraxofusp will be administered by intravenous infusion for 3 consecutive days during each 28-day cycle.
Other Names:
  • Elzonris
  • Tag
Drug: Venetoclax
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.
Other Names:
  • Venclexta
  • Ven

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
Cycles 1-4 (up to 112 days; 28 days/cycle)
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)
Cycles 1-4 (up to 112 days; 28 days/cycle)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parts 1 and 2: Number of Participants Achieving a BOR of CR
Time Frame: Cycles 1-6 (up to 168 days; 28 days/cycle)
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)
The time to first CR will be defined as the time from randomization (Cycle 1, Day 1) to the date of first documented CR.
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)
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)
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)
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.
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)
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)
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.
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
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.
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)
Defined as the number of participants with a presence of marrow MRD of less than 0.01% at the time of CR.
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
Up to approximately 6 years
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)
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
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.
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
Up to approximately 6 years
Parts 1 and 2: Overall Survival
Time Frame: Up to approximately 6 years
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)
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)
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)
Predose, up to 8 hours post dose (Days 4, 5, 6, 7, 14; Cycles 1-4; 28 days/cycle)
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)
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)
Predose, up to 8 hours post dose (Days 4, 5, 6, 7, 14; Cycles 1-4; 28 days/cycle)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 9, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STML-401-0423
  • U1111-1290-9087 (Other Identifier: UTN)
  • 2024-514660-48 (Other Identifier: EU CT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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