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This study examines the use of the drug TGRX-678 in patients with chronic myeloid leukemia (CML). It is enrolling CML patients aged 18 and older whose disease is resistant to or has relapsed after third-generation tyrosine kinase inhibitor treatment. It is being run as a Phase 2 study and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Willing to consent * 18 years of age or above at time of screening; both sexes eligible * Relapsed or refactory from 3rd-generation Tyrosine kinase inhibitor (TKI) treatment * For patients without T315I mutation, the patients must received 1st, 2nd and 3rd generation TKI * For patients with T315I mutation, the patients much received Olverembatinib or Ponatinib treatment * Diagnosis of CML-AP by bone marrow morphological test, molecular biology test or cytogenetic tests * ECOG score \</=2 * Minimum life expectancy of at least 3 months * Adequate hematological indicators * Adequate kidney function * Adequate liver function * Adequate coagulation function * Adequate pancreatic function * Adequate QTc interval as confirmed by electrocardiogram (ECG) test * Negative pregnancy result at screening for female patients of child-bearing potential * Willing to take contraceptive measure during the study (For male and female patients of child-bearing potential) Exclusion Criteria: * Reception of TKI treatment or presence of unrecovered TKI treatment related non-hematological adverse events within 7 days of first dose * Reception of other anti-tumor treatments * In need for immune suppressive treatment * Usage of drugs associated with Torsades de Pointes within 1 months before screening * Presence of other medical conditions that require using treatment that may have drug-drug interaction with the investigational drug * History of hemapoietic stem cell transplant * Presence of active central nervous system conditions * CML-AP patients who already reached major hematological response * CML-AP patients who used to progress to Blast Phase (BP) * Presence or having uncontrolled condition for cardiovascular diseases * History of any heart or cardiovascular conditions (except for patients with hypertension which is controlled by anti-hypertensive drugs, and blood pressure is controlled at no higher than 160/100 mmHg for 1 months before screening) * Usage of any Traditional Chinese Medicine indicated for anti-tumor purpose 2 weeks before first dose * Severe hemorrhagic disease unrelated to CML * History of severe cardiovascular condition during past TKI treatment for CML * History of pancreatic inflammation or alcohol abuse within 3 years before first dose * Uncontrolled Hypertriglyceridemia * Presence of malabsorption or other conditions that may affect drug absorption * Diagnosis of other primary malignant tumor within 5 years * Reception of major surgery 14 days before first dose * Presence of continuous or active infection (including HIV, hepatitis B, hepatitis C) * Presence of other conditions that the investigators or medical monitor deem unfit for the study