Phase I Study Of PLM-102 In Patients With Relapsed And Refractory Acute Myeloid Leukemia
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to find the highest tolerable dose of PLM-102 that can be given to patients who have AML/MDS that is refractory and/or relapsed. The safety of PLM-102 will also be studied.
Description
Primary Objective: To study the safety and tolerability of PLM-102 in terms of treatment emergent adverse events (TEAE) and dose limiting toxicities (DLT). To establish the RP2D of PLM-102 based on the totality of the data. Secondary Objectives: To estimate rate of CR/CRh by 4 cycles of treatment To estimate overall response rate (ORR=CR/CRh/CRi/MLFS/PR) by 4 cycles of treatment To determine duration of response (DOR) of CR/CRh To determine overall survival (OS) Exploratory Objectives: To characterize the pharmacokinetics (PK) of PLM-102 and its metabolite(s) To characterize pharmacodynam…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Patients need to be adults with R/R AML or MDS/AML per the ICC 2022 or the WHO 2022.4,5 1. Relapsed or refractory disease following standard treatment: 1. Relapsed: Bone marrow blasts ≥5%, reappearance of blasts in the blood, or development of extramedullary disease following achievement of CR/CRi/MLFS 2. Refractory: Failure to achieve CR/CRi/MLFS following initial treatment, with evidence of persistent leukemia by blood and/or bone marrow evaluation with blasts ≥5% 2. ECOG PS 0 to 2 3. Patients with actionable mutations with available FDA-approved therapies, e.g.,…
Interventions
- DrugPLM-102
Given by mouth
Location
- UT MD AndersonHouston, Texas