NCT06453902招募中2 期
A Single-arm, Open-label, Multi-center Phase II Study Evaluating Efficacy and Safety of TGRX-678 in CML-AP Patients Relapsed or Refractory from 3rd-generation TKI Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Major Hematologic Response (MaHR)
研究概览
简要总结
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
详细描述
This Phase II study is of single-arm, open-label and multi-center designs to study safety and efficacy profiles of TGRX-678 in CML-AP patients. Patients need to have medical history of failing treatment(s) from third-generation TKI drugs. Patients with or without T315I mutation is enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Experimental: TGRX-678
Experimental
All patients with CML-AP to be treated with TGRX-678. Patients with T315I mutation or without T315I mutation will be assigned into separate cohorts for evaluation
干预措施: TGRX-678 (Drug)
结局指标
主要结局
Major Hematologic Response (MaHR)
时间窗: At screening, on Day 1 of every treatment cycle (each cycle is 28 days) and at end of treatment; average of study duration is 3.5 years
Number of patients who reached, and rate of occurence of major hematologic response, including those who reached complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR and NEL are defined per China national treatment guideline for CML (ver. 2022). Indicators for hematologic responses will be obtained via peripheral blood tests.
次要结局
- Time to Response (TTR)(At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years)
- Cytogenetic Response(At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years)
- Major Molecular Response (MMR)(At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years)
- Progression Free Survival (PFS)(At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years)
- Overall Survival (OS)(At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years)
- Duration of Response (DOR)(At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years)
- Treatment Emergent Adverse Event (TEAE)(Through completion of the study, an average of 3.5 years)
研究者
研究点 (1)
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