TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients
A Phase II study evaluating the safety and efficacy of TGRX-678 in Chronic Myelogenous Leukemia (CML) patients in Accelerated phase (AP) and are relapsed or refractory from third-generation Tyrosine Kinase Inhibitor (TKI) treatment
| Condition(s) | Chronic Myeloid Leukemia, Accelerated Phase CML |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | A Phase II study evaluating the safety and efficacy of TGRX-678 in Chronic Myelogenous Leukemia (CML) patients in Accelerated phase (AP) and are relapsed or refractory from third-generation Tyrosine Kinase Inhibitor (TKI) treatment |
| Who can participate | 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 pregna |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Shenzhen TargetRx Co., Ltd. |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2024-07-15 |
| NCT ID | NCT06453902 |
| Official listing | https://clinicaltrials.gov/study/NCT06453902 |