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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06456463
Other study ID # STML-401-0423
Secondary ID 2024-514660-48-0
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date August 30, 2024
Est. completion date February 11, 2030

Study information

Verified date June 2024
Source Stemline Therapeutics, Inc.
Contact Stemline Trials
Phone 1-877-332-7967
Email clinicaltrials@menarinistemline.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will be divided into 2 parts (Part 1 and Part 2). Part 1 will evaluate 2 doses of tagraxofusp, 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. Both parts will be conducted in participants with previously untreated CD123+ AML who are ineligible for intensive chemotherapy.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 76
Est. completion date February 11, 2030
Est. primary completion date February 9, 2028
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Key Inclusion Criteria: - Histologically confirmed newly diagnosed AML with bone marrow blast count =20%. - Participant has any level of CD123 expression on blasts determined centrally by flow cytometry. - For participants between 60 and 74 years of age, 1 of the following comorbidities is required: - Eastern Cooperative Oncology Group (ECOG) Score of 2 or 3. - Diffusing capacity of lung for carbon monoxide of =65% or forced expiratory volume of 1 second =65%. - Creatinine clearance =30 to <45 milliliters/minute. - Moderate hepatic impairment with total bilirubin >1.5 to =3.0 x upper limit of normal. - Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Sponsor and Medical Monitor prior to enrollment. - ECOG performance status: - If =75 years of age, ECOG 0 to 2 - If =60 to 74 years of age, ECOG 0 to 3 Key Exclusion Criteria: - Participant has received prior therapy for AML. - Willing and able to receive standard induction therapy. - Treatment for an antecedent hematologic disease with any of the following: - A hypomethylating agent, venetoclax, tagraxofusp, purine analogue, cytarabine, intensive chemotherapy. - Chimeric antigen receptor-T therapy or other experimental therapies. - AML with central nervous system involvement. Note: Other inclusion/exclusion criteria may apply.

Study Design


Intervention

Drug:
Tagraxofusp
Tagraxofusp will be administered by intravenous infusion.
Venetoclax
Venetoclax will be administered as an oral tablet.
Azacitidine
Azacitidine will be administered subcutaneously or by intravenous infusion.

Locations

Country Name City State
United States Dana Farber Cancer Institute (DFCI) Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Cleveland Clinic Foundation Cleveland Ohio
United States Baylor Scott & White Health Dallas Texas
United States University of Texas MD Anderson Cancer Center Houston Texas
United States University of California, Los Angeles Los Angeles California
United States Mt. Sinai - Ruttenberg Treatment Center New York New York
United States Washington University - Siteman Cancer Center Saint Louis Missouri
United States Hunstman Cancer Institute Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Stemline Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Secondary Parts 1 and 2: Number of Participants Achieving a BOR of CR Cycles 1-6 (up to 168 days; 28 days/cycle)
Secondary 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. Cycles 1-6 (up to 168 days; 28 days/cycle)
Secondary Parts 1 and 2: Duration of Response Cycles 1-6 (up to 168 days; 28 days/cycle)
Secondary 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)
Secondary 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)
Secondary Parts 1 and 2: Number of Participants Achieving a BOR of CR or CRi Cycles 1-6 (up to 168 days; 28 days/cycle)
Secondary 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)
Secondary 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
Secondary 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)
Secondary Parts 1 and 2: Number of Participants Who Bridged to Stem Cell Transplant (SCT) Through Study Treatment Up to approximately 6 years
Secondary Parts 1 and 2: Plasma Concentration of Free Tagraxofusp, Venetoclax, and Azacitidine Predose, up to 8 hours post dose (Days 4, 5, 6, 7, 14; Cycles 1-6; 28 days/cycle)
Secondary 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)
Secondary 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
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