Actively Recruiting
APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML
Led by Aptevo Therapeutics · Updated on 2025-05-11
39
Participants Needed
7
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multi-center, open-label, dose-finding study of five dose levels of APVO436 in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML.
CONDITIONS
Official Title
APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of AML based on 2016 WHO criteria with no prior treatment
- CD123-positive AML confirmed by local testing
- Ineligible for induction therapy due to at least one of the following: 75 years or older, ECOG Performance Status of 2 or 3, cardiac disorder requiring treatment or low ejection fraction, pulmonary disorder with low lung function, creatinine clearance 30-45 mL/min, or hepatic disorder with elevated bilirubin
- Projected life expectancy of at least 12 weeks
You will not qualify if you...
- Prior treatment with hypomethylating agents, venetoclax, chemotherapy for AML, MDS, CMML, or MPS/MPN
- Previous CAR-T therapy or allogeneic hematopoietic stem cell transplant
- Use of experimental therapies for MDS or AML
- Current participation in another interventional study
- History of certain blood cancers including MPN or AML with BCR-ABL1 translocation
- Diagnosis of acute promyelocytic leukemia
- Autoimmune disorder requiring significant immunosuppressive therapy
- Receiving corticosteroid therapy as cancer treatment
- Active central nervous system involvement with AML
- Creatinine clearance below 30 mL/min
- Bilirubin above 3 times upper limit of normal without Gilbert's Syndrome
- Elevated liver enzymes AST or ALT over 3 times upper limit of normal
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
2
University of Miami
Miami, Florida, United States, 33124
Actively Recruiting
3
University of Kansas
Fairway, Kansas, United States, 66205
Actively Recruiting
4
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Actively Recruiting
5
Oncology Hematology Care
Cincinnati, Ohio, United States, 45226
Actively Recruiting
6
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
7
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Caroline Taromino
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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