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.
Relapsed: Bone marrow blasts ≥5%, reappearance of blasts in the blood, or development of extramedullary disease following achievement of CR/CRi/MLFS
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%
ECOG PS 0 to 2
Patients with actionable mutations with available FDA-approved therapies, e.g., FLT3, IDH1/2, menin inhibitors may be enrolled after they have exhausted or are ineligible for appropriate lines of FDA approved treatment options.
Prior use of any cytotoxic chemotherapy, targeted therapy, radiation therapy, immunotherapy, or other clinical trial therapies within 2 weeks, prior to first dose of study treatment. Patients should have recovered from all prior therapy related toxicities. Patients may receive hydroxyurea or cytarabine for control of WBC count during this washout period.
Patient has uncontrolled systemic fungal, bacterial, viral or other infection with ongoing signs/symptoms despite appropriate treatment.
Patients with any severe gastrointestinal or metabolic condition or gastric bypass, which could interfere with absorption of oral drug.
Active uncontrolled comorbidities including decompensated congestive heart failure NYHA class III/IV, clinically significant, uncontrolled arrhythmia, acute respiratory failure, unstable or decompensated pulmonary disease, as judged by the treating physician.