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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1290-9087 | Other Identifier | UTN | |
| 2024-514660-48 | Other Identifier | EU CT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 - Tagraxofusp (9 μg/kg/day) | Experimental | Participants will receive tagraxofusp in combination with venetoclax and azacitidine. |
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| Part 1 - Tagraxofusp (12 μg/kg/day) | Experimental | Participants will receive tagraxofusp in combination with venetoclax and azacitidine. |
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| Part 2 - Tagraxofusp (Selected Dose) and TP53 Wild Type | Experimental | Participants (TP53 wild type) will receive tagraxofusp in combination with venetoclax and azacitidine. |
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| Part 2 - Tagraxofusp (Selected Dose) and TP53 Mutated | Experimental | Participants (TP53 mutated) will receive tagraxofusp in combination with venetoclax and azacitidine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tagraxofusp | Drug | Tagraxofusp will be administered by intravenous infusion for 3 consecutive days during each 28-day cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Determination of Part 2 Selected Dose of Tagraxofusp When Administered in Combination with Venetoclax and Azacitidine | 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) | Cycles 1-4 (up to 112 days; 28 days/cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Parts 1 and 2: Number of Participants Achieving a BOR of CR | 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. |
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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:
ECOG performance status:
Key Exclusion Criteria:
Note: Other inclusion/exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stemline Trials | Contact | 1-877-332-7961 | clinicaltrials@menarinistemline.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
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.
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| Venetoclax | Drug | 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. |
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| Azacitidine | Drug | 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. |
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| Cycles 1-6 (up to 168 days; 28 days/cycle) |
| Parts 1 and 2: Duration of Response | 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) | 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. | Cycles 1-4 (up to 112 days; 28 days/cycle) |
| Parts 1 and 2: Number of Participants Achieving a BOR of CR or CRi | 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. | 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. | 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. | 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 | Up to approximately 6 years |
| Part 1: Plasma Concentration of Free Tagraxofusp, Venetoclax, and Azacitidine | 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 | 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 | 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. | Up to approximately 6 years |
| Parts 1 and 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to approximately 6 years |
| Parts 1 and 2: Overall Survival | Up to approximately 6 years |
| Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Tagraxofusp and Venetoclax | 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 | 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 | Predose, up to 8 hours post dose (Days 4, 5, 6, 7, 14; Cycles 1-4; 28 days/cycle) |
| Stanford Health Care | Recruiting | Stanford | California | 94305 | United States |
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| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| AdventHealth Cancer Institute | Recruiting | Orlando | Florida | 32804 | United States |
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| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| Dana Farber Cancer Institute (DFCI) | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Henry Ford Health System Brigitte Harris Cancer Pavillion | Recruiting | Detroit | Michigan | 48202 | United States |
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| Washington University - Siteman Cancer Center | Recruiting | St Louis | Missouri | 63110 | United States |
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| John Theurer Cancer Center - Hackensack Meridian Health | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Rutgers Cancer Institute | Recruiting | New Brunswick | New Jersey | 08901 | United States |
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| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14203 | United States |
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| North Shore University Hospital | Recruiting | Manhasset | New York | 11030 | United States |
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| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
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| Novant Health Presbyterian Medical Center | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| Novant Health Derrick L Davis Cancer Center | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
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| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Sydney Kimmel (Thomas Jefferson University) | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| Sarah Cannon, the Cancer Institute of HCA Healthcare | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Tennessee Oncology | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Baylor Scott & White Health | Recruiting | Dallas | Texas | 75246 | United States |
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| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Concord Repatriation General Hospital | Recruiting | Concord | New South Wales | 2139 | Australia |
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| Townsville Hospital | Recruiting | Douglas | Queensland | 4814 | Australia |
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| Royal Adelaide Hospital | Recruiting | Adelaide | South Australia | 5000 | Australia |
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| Box Hill Hospital | Recruiting | Box Hill | Victoria | 3128 | Australia |
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| Monash Medical Centre | Recruiting | Clayton | Victoria | 3168 | Australia |
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| St. Vincents Hospital | Recruiting | Fitzroy | Victoria | 3065 | Australia |
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| Austin Hospital | Recruiting | Heidelberg | Victoria | 3084 | Australia |
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| Royal Perth Hospital | Recruiting | Perth | Western Australia | 6000 | Australia |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000592123 | tagraxofusp |
| D011356 | Product Labeling |
| C579720 | venetoclax |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D019064 | Product Packaging |
| D007221 | Industry |
| D013676 | Technology, Industry, and Agriculture |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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