Phase1b/2 Trial Of AZA + APG1252 In Patients With High-Risk AML
M.D. Anderson Cancer Center
Summary
This is a phase Ib/II study that aims to investigate the safety, tolerability and explore the efficacy of BCL- XL inhibition in participants with high-risk AML.
Description
Primary Objectives: Phase Ib: To evaluate the safety, tolerability, and maximum tolerated dose of APG1252 in combination with Azacitidine in patients with relapsed or refractory (R/R) high-risk Acute Myeloid Leukemia (AML) Phase II: To evaluate the initial efficacy information in terms of ORR (CR/CRi/MLFS). Secondary Objectives: * \[Phase Ib\] To evaluate response (complete response \[CR\] including complete response without blood count recovery \[CRi\] or marrow leukemia free state \[MLFS\]) of APG1252 in combination with Azacitidine * \[Phase Ib and Phase II\] To evaluate the event free…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Part I, Lead-in phase and Part II, Cohort A: Patients with relapsed and/or refractory AML Patients with high-risk MDS/AML who have had prior therapy will also be included 2. Part II, Cohort B Patients with untreated, newly diagnosed AML of the following subtypes: * AML-M6 or AML-M7 by FAB or having erythroid or megakaryocytic differentiation by WHO 2022 classification * High-risk MDS/AML with erythroid differentiation and no prior therapy * AML with MECOM rearrangement, including, but not limited to t(3;3), inv(3q), confirmed by conventional karyotype o…
Interventions
- DrugAzacitidine
Given by IV
- DrugAPG1252
Given by IV
Location
- UT MD AndersonHouston, Texas