JPRN-jRCT2021210060进行中（未招募）3 期
A phase III, multi-center, open-label, randomized study of oral asciminib versus Investigator selected Tyrosine Kinase Inhibitor (TKI) in adult patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase
Kazuyuki Suzuki0 个研究点目标入组 36 人开始时间: 2021年12月26日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participants eligible for inclusion in this study must meet all of the following criteria:
- •1. Male or female patients >= 18 years of age.
- •2. Patients with CML-CP within 3 months of diagnosis.
- •3. Diagnosis of CML-CP with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations (presence of BCR-ABL1 in a review of a minimum 20 metaphases is required).
- •Documented chronic phase CML will meet all the below criteria:
- •- < 15% blasts in peripheral blood and bone marrow,
- •- < 30% blasts plus promyelocytes in peripheral blood and bone marrow,
- •- < 20% basophils in the peripheral blood,
- •- Platelet (PLT) count >= 100 x 109/L (>=100,000/mm3),
- •- No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1.
- •5. Adequate end organ function as defined by:
- •- Total bilirubin (TBL) < 3 x upper limit of normal (ULN); patients with Gilbert's syndrome may only be included if TBL =< 3.0 x ULN or direct bilirubin =< 1.5 x ULN
- •- Creatinine clearance (ClCr) >= 30 mL/min as calculated using Cockcroft-Gault formula
- •- Serum lipase =< 1.5 x ULN. For serum lipase > ULN - =< 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis
- •6. Patients must have the following laboratory values >= lower limit of normal (LLN) or corrected to within normal limits with supplements prior to randomization:
- •- Potassium (potassium increase of up to 6.0 mmol/L is acceptable if associated with ClCr* >= 90 mL/min)
- •- Total calcium (corrected for serum albumin); (calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable if associated with ClCr* >= 90 mL/min)
- •- Magnesium (magnesium increase of up to 3.0 mg/dL or 1.23 mmol/L if associated with ClCr* >= 90 mL/min)
- •- For patients with mild to moderate renal impairment (ClCr* >= 30 mL/min and <90 mL/min) - potassium, total calcium (corrected for serum albumin) and magnesium should be >= LLN or corrected to within normal limits with supplements prior to randomization. ClCr* as calculated using Cockcroft-Gault formula
- •7. Signed informed consent must be obtained prior to any study related screening procedures being performed.
- •8. Evidence of typical BCR-ABL1 transcript [e14a2 and/or e13a2] at the time of screening which is amenable to standardized Real time quantitative polymerase chain reaction (RQ-PCR) quantification.
排除标准
- •Participants meeting any of the following criteria are not eligible for inclusion in this study:
- •1. Previous treatment of CML with any other anticancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea and/or anagrelide. Treatment with imatinib for =<2 weeks is allowed, but no other treatment with tyrosine kinase inhibitors prior to study entry is permitted.
- •2. Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
- •3. Impaired cardiac function or cardiac repolarization abnormality including but not limited to any one of the following:
- •- History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG).
- •- Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block).
- •- QTc >= 450 msec (male patients), >=460 msec (female patients) on the average of three serial baseline ECG (using the QTcF formula) as determined by central reading. If QTcF >= 450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc.
- •- Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
- •- Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
- •- Concomitant medication(s) with a 'Known risk of Torsades de Pointes' per www.crediblemeds.org/ that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication.
- •- Inability to determine the QTcF interval.
- •4. Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection; uncontrolled arterial or pulmonary hypertension, uncontrolled clinically significant hyperlipidemia).
- •5. History of significant congenital or acquired bleeding disorder unrelated to cancer.
- •6. Major surgery within 4 weeks prior to study entry or who have not recovered from prior surgery.
- •7. History of other active malignancy within 3 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively.
- •8. History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis.
- •9. History of chronic liver disease leading to severe hepatic impairment, or ongoing acute liver disease.
- •10. Known history of chronic Hepatitis B (HBV), or chronic Hepatitis C (HCV) infection. Testing for Hepatitis B surface antigen (HBs Ag) and Hepatitis B core antibody (HBc Ab/anti HBc) will be performed at screening. A patient having positive HBV-DNA should not be enrolled in the study.
- •11. History of Human Immunodeficiency Virus (HIV) unless well-controlled on a stable dose of anti-retroviral therapy at the time of screening.
- •12. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome,
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