Actively Recruiting
A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL
Led by Ascentage Pharma Group Inc. · Updated on 2025-11-04
78
Participants Needed
1
Research Sites
307 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to evaluate the pharmacokinetics (PK), safety, and efficacy of APG-115 as a single agent or in combination with APG-2575 in patients with T-PLL and NHL.
CONDITIONS
Official Title
A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with relapsed or refractory T-cell prolymphocytic leukemia with active disease and at least one prior therapy
- Diagnosed with histologically confirmed non-Hodgkin's lymphoma that is relapsed, refractory, intolerant, or ineligible for known beneficial therapies
- No chemotherapy or antibody therapy within 7 days before starting study drugs; hydroxyurea or decadron allowed until 24 hours before starting if disease is rapidly growing
- Absolute neutrophil count (ANC) of at least 500/mm3, hemoglobin at least 60 g/L, and platelet count at least 30,000/mm3
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Ability to understand study requirements and provide signed informed consent
You will not qualify if you...
- Previous treatment with an MDM2 inhibitor
- Active, uncontrolled central nervous system malignancy
- Need for graft versus host therapy or ongoing systemic immunosuppressive treatment (calcineurin inhibitors within 4 weeks before study drug)
- Any condition or illness that may compromise safety or interfere with evaluating the study drugs
- Use of strong CYP2C8 inhibitors or moderate to strong CYP3A4 inhibitors or inducers within 14 days or 7 half-lives before the first dose of study drugs, whichever is longer
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
G
Genevieve Frank
CONTACT
J
Jocelyn Budzynski
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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