Actively Recruiting
A Phase 1b/2 Open-Label Study of APVO436 in Combination With Venetoclax and Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Led by Aptevo Therapeutics · Updated on 2025-05-11
39
Participants Needed
7
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating APVO436 in combination with venetoclax and azacitidine for adults newly diagnosed with CD123-positive acute myeloid leukemia (AML). This study is a Phase 1b/2 open-label trial designed to find the safest and most effective dose of APVO436 when used with these drugs. The trial focuses on patients who have not received prior treatment and are considered ineligible for standard induction therapy due to factors like age or health conditions. Treatment involves five dose levels of APVO436 given with venetoclax and azacitidine. In the first 28-day cycle, patients receive four initial priming doses of APVO436 to reduce the risk of cytokine release syndrome, followed by doses administered on day 15 and in subsequent cycles. APVO436 is given by a 4-hour intravenous infusion, venetoclax is taken orally on days 1 through 22, and azacitidine is delivered by IV infusion on days 1 to 8 of each 28-day cycle. Participants will attend regular treatment cycles where safety, tolerability, and dosing effects are closely monitored through clinical assessments. Researchers will evaluate the maximum tolerated dose and measure treatment efficacy over approximately one year. The study includes detailed monitoring of side effects and patient response to the combination therapy, with ongoing follow-up until study completion.
CONDITIONS
Brief 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
- Considered ineligible for induction therapy due to one or more of: age 75 years or older, ECOG performance status 2 or 3, certain cardiac or pulmonary disorders, creatinine clearance 30-45 mL/min, or elevated bilirubin levels
- Projected life expectancy of at least 12 weeks
You will not qualify if you...
- Previous treatment with hypomethylating agents, venetoclax, chemotherapy for AML or related disorders
- Prior CAR-T therapy or allogeneic stem cell transplant
- Participation in another interventional clinical trial
- History of certain myeloproliferative neoplasms or AML with BCR-ABL1 translocation
- Acute promyelocytic leukemia diagnosis
- Current autoimmune disorder requiring immunosuppressive therapy above specified doses
- Concurrent corticosteroid therapy as anticancer 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
- AST or ALT greater than 3 times upper limit of normal
- Other experimental therapies for related blood disorders
- Use of systemic steroids over defined limits as immunosuppression
- Active CNS AML involvement except prophylactic intrathecal chemotherapy prior to enrollment
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28-day cycles until disease progression or discontinuation
Participants receive APVO436 by 4-hour intravenous infusion in combination with oral venetoclax and intravenous azacitidine in repeated 28-day cycles. In Cycle 1, participants receive 4 priming doses of APVO436 to reduce risk of CRS, followed by dosing on Day 15 and all subsequent doses at the determined dose level.
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
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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