A Phase 1b/2 Open-Label Study of APVO436 in Combination With Venetoclax and Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. Age ≥18 years. 2. Patient must have confirmation of AML based on 2016 World Health Organization (WHO) criteria and not been previously treated.

• 3\. Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry \[IHC\]). Confirmation at diagnosis is acceptable.

• 4\. Patient must be considered ineligible for induction therapy defined by at least one of the following:

⁃ ≥75 years of age

⁃ Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3

⁃ Cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)

⁃ Pulmonary disorder (e.g., DLCO ≤65% or FEV1 ≤65%)

⁃ Creatinine clearance 30-45 mL/min based on Cockcroft-Gault or Modified of Diet in Renal Disease (MDRD) formular

⁃ Hepatic disorder with total bilirubin between 1.5 and 3 times the ULN 5. Patient must have a projected life expectancy of ≥12 weeks

Locations
United States
Colorado
Colorado Blood Cancer Institute
RECRUITING
Denver
Florida
University of Miami
RECRUITING
Miami
Kansas
University of Kansas
RECRUITING
Fairway
Ohio
Gabrail Cancer Center
RECRUITING
Canton
Oncology Hematology Care
RECRUITING
Cincinnati
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Caroline Taromino
tarominoC@apvo.com
7735749572
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2028-03
Participants
Target number of participants: 39
Treatments
Experimental: Treatment Arm APVO436 in combination with Venetoclax and Azacitidine
APVO436 at escalating dose levels in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML.
Related Therapeutic Areas
Sponsors
Leads: Aptevo Therapeutics

This content was sourced from clinicaltrials.gov

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