Trial Title:
A Study of Tagraxofusp in Combination with Venetoclax and Azacitidine in Adults with Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
NCT ID:
NCT06456463
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Venetoclax
Conditions: Keywords:
CD123+
Tagraxofusp
Venetoclax
Azacitidine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tagraxofusp
Description:
Tagraxofusp will be administered by intravenous infusion on days 4, 5, and 6 of each
28-day cycle.
Arm group label:
Part 1 - Tagraxofusp (12 μg/kg/day)
Arm group label:
Part 1 - Tagraxofusp (9 μg/kg/day)
Arm group label:
Part 2 - Tagraxofusp (Selected Dose) and TP53 Mutated
Arm group label:
Part 2 - Tagraxofusp (Selected Dose) and TP53 Wild Type
Other name:
Tag
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Venetoclax will be administered as an oral tablet (400 milligrams) daily of each 28-day
cycle.
Arm group label:
Part 1 - Tagraxofusp (12 μg/kg/day)
Arm group label:
Part 1 - Tagraxofusp (9 μg/kg/day)
Arm group label:
Part 2 - Tagraxofusp (Selected Dose) and TP53 Mutated
Arm group label:
Part 2 - Tagraxofusp (Selected Dose) and TP53 Wild Type
Other name:
Ven
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
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.
Arm group label:
Part 1 - Tagraxofusp (12 μg/kg/day)
Arm group label:
Part 1 - Tagraxofusp (9 μg/kg/day)
Arm group label:
Part 2 - Tagraxofusp (Selected Dose) and TP53 Mutated
Arm group label:
Part 2 - Tagraxofusp (Selected Dose) and TP53 Wild Type
Other name:
Aza
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. 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.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Previously untreated with histological confirmation of AML by World Health
Organization 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 determined centrally by flow
cytometry.
- 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 comorbidities:
- 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%.
- Left ventricular ejection fraction ≤50%.
- 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 comorbidity that the investigator judges to be incompatible with
intensive chemotherapy must be reviewed and approved by the Sponsor and
Medical Monitor prior to enrollment.
- ECOG performance status:
- Of 0 to 2 for participants if ≥75 years of age, or
- Of 0 to 3 for participants ≥18 to 74 years of age.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, Los Angeles
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Contact:
Last name:
Gary Schiller, MD
Facility:
Name:
University of Miami Sylvester Comprehensive Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Contact:
Last name:
Namrata S Chandhok, MD
Facility:
Name:
AdventHealth Cancer Institute
Address:
City:
Orlando
Zip:
32804
Country:
United States
Contact:
Last name:
Shahram Mori, MD, PhD
Facility:
Name:
Dana Farber Cancer Institute (DFCI)
Address:
City:
Boston
Zip:
02114
Country:
United States
Contact:
Last name:
Andrew A Lane, MD, PhD
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Contact:
Last name:
Amir Fathi, MD
Facility:
Name:
Henry Ford Health
Address:
City:
Detroit
Zip:
48202
Country:
United States
Contact:
Last name:
Christopher A Willner II, DO
Facility:
Name:
Washington University - Siteman Cancer Center
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Facility:
Name:
John Theurer Cancer Center - Hackensack Meridian Health
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Contact:
Last name:
James K McCloskey, MD
Facility:
Name:
Rutgers Cancer Institute
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Contact:
Last name:
Neil D Palmisiano, MD, MS
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14203
Country:
United States
Contact:
Last name:
Eunice S Wang, MD
Facility:
Name:
North Shore University Hospital
Address:
City:
Manhasset
Zip:
11030
Country:
United States
Contact:
Last name:
David Chitty, MD
Facility:
Name:
NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Contact:
Last name:
Jun H Choi, MD
Facility:
Name:
Columbia University Irving Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Contact:
Last name:
Sunil Iyer, MD
Facility:
Name:
Novant Health Presbyterian Medical Center
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Contact:
Last name:
Abhishek Chilkulwar, MD
Facility:
Name:
Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Contact:
Last name:
Hetty E Carraway, MD, MBA
Facility:
Name:
Lifespan Cancer Institute
Address:
City:
Providence
Zip:
02903
Country:
United States
Contact:
Last name:
Rabin Niroula, MD
Facility:
Name:
Sarah Cannon, the Cancer Institute of HCA Healthcare
Address:
City:
Nashville
Zip:
37203
Country:
United States
Contact:
Last name:
Stephen A Strickland, MD
Facility:
Name:
Tennessee Oncology
Address:
City:
Nashville
Zip:
37203
Country:
United States
Contact:
Last name:
Jonathan Abbas, MD
Facility:
Name:
Baylor Scott & White Health
Address:
City:
Dallas
Zip:
75246
Country:
United States
Contact:
Last name:
Bradley W Christensen, MD
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Contact:
Last name:
Naval G Daver, MD
Facility:
Name:
Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84132
Country:
United States
Contact:
Last name:
Srinivas K Tantravahi, MBBS, MRCP
Facility:
Name:
Concord Repatriation General Hospital
Address:
City:
Concord
Zip:
2139
Country:
Australia
Contact:
Last name:
Robin Gasiorowski, MBBS
Facility:
Name:
Townsville Hospital
Address:
City:
Townsville
Zip:
4814
Country:
Australia
Contact:
Last name:
Hock-Choong Lai, MBBS
Facility:
Name:
Royal Adelaide Hospital
Address:
City:
Adelaide
Zip:
5000
Country:
Australia
Contact:
Last name:
Devendra Hiwase, MBBS
Facility:
Name:
Box Hill Hospital
Address:
City:
Box Hill
Zip:
3128
Country:
Australia
Contact:
Last name:
Stephen Ting, MBBS
Facility:
Name:
Monash Medical Centre
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Contact:
Last name:
Chong Chyn Chua, MBBS, PhD
Facility:
Name:
St. Vincents Hospital
Address:
City:
Fitzroy
Zip:
3065
Country:
Australia
Contact:
Last name:
Shuh Ying Tan, MBBS
Facility:
Name:
Austin Hospital
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Contact:
Last name:
Chun Yew Fong, MBBS, PhD
Facility:
Name:
National Cancer Center
Address:
City:
Goyang-si
Country:
Korea, Republic of
Contact:
Last name:
Hyewon Lee, MD, MS
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Country:
Korea, Republic of
Contact:
Last name:
Soo-Mae Bang, MD, PhD
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Contact:
Last name:
Chul Won Jung, MD, PhD
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Contact:
Last name:
Inho Kim, MD, MS
Facility:
Name:
Seoul St. Mary's Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Contact:
Last name:
Hee Je Kim, MD
Facility:
Name:
Severance Hospital, Yonsei University
Address:
City:
Seoul
Country:
Korea, Republic of
Start date:
November 30, 2024
Completion date:
February 11, 2030
Lead sponsor:
Agency:
Stemline Therapeutics, Inc.
Agency class:
Other
Source:
Stemline Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06456463
