EUCTR2010-018419-14-GB进行中（未招募）1 期
A multi-center, open-label, pharmacokinetic study of oral nilotinib in pediatric patients with newly diagnosed chronic phase (CP) Ph+ CML, with CP or accelerated phase (AP) Ph+ CML resistant/intolerant to imatinib and/or dasatinib, or with refractory/relapsed Ph+ ALL.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Male or female patients less than 18 years and more than 1 year of age at study entry.
- •2.Written informed consent, according to local guidelines, signed by the patients and / or by the parents or legal guardian prior to any study
- •related screening procedures are performed.
- •3.Patients must have one of the following: newly diagnosed CP Ph+
- •CML,or CP or AP Ph+ CML resistant/ intolerant to imatinib and/or
- •dasatinib, or Ph+ CML CP or AP or Ph+ ALL either relapsed after or
- •refractory to standard therapy.
- •a. Imatinib or dasatinib resistance in Ph+ CML is defined as:
- •Increasing WBC or platelet count while on imatinib or dasatinib
- •therapy indicative of a hematological relapse or primary resistance to
- •imatinib or dasatinib.
- •Cytogenetic or molecular response consistent with suboptimal
- •response or failure criteria adapted from ELN (European Leukemia Net)
- •recommendations
- •Progression to accelerated phase or blast crisis while on imatinib or
- •dasatinib therapy.
- •Reappearance of Ph+ bone marrow cells after a complete cytogenetic
- •response to imatinib or dasatinib.
- •A greater than 30% increase in Ph+ cells in peripheral blood or on
- •bone marrow cytogenetics while on imatinib or dasatinib therapy.
- •Loss of molecular response on imatinib or dasatinib therapy.
- •b. Imatinib/dasatinib intolerance (at any dose or duration) is defined as
- •the development of AEs requiring discontinuation of imatinib or
- •dasatinib therapy.
- •c. Newly diagnosed CP Ph+ CML is defined as:
- •Patients with Ph+ CML-CP within 6 months of diagnosis (date of initial
- •diagnosis is the date of first cytogenetic analysis).
- •Diagnosis of chronic myelogenous leukemia in chronic phase with
- •cytogenetic confirmation of Philadelphia chromosome with
- •(9;22)translocation (to confirm the presence of BCR-ABL and review of a
- •minimum 20 metaphases is required). Standard conventional
- •cytogenetic analysis must be done on bone marrow. FISH cannot be used for study purposes.
- •4. Performance status: Karnofsky = 50% for patients > 10 years of age,
- •and Lansky = 50 for patients = 10 years of age.
- •5. Patients must have adequate renal, hepatic and pancreatic function
- •defined as:
- •Creatinine clearance or radioisotope GFR ‡ 70 ml/min/1.73 m2, or a
- •serum creatinine based on age
- •Total bilirubin (sum of conjugated + unconjugated) £ 1.5 x upper limit of normal (ULN) for age.
- •Serum amylase and lipase = 1.5 x ULN
- •SGPT (ALT) and SGOT (AST) £ 2 x upper limit of normal (ULN) for age.
- •6. Female patients of childbearing potential who agree to abstinence or,
- •if sexually active, agree to the use of contraception.
- •7. Patients must have the following laboratory values (=LLN (lower limit
- •of normal)) or corrected to within normal limits with supplements prior
排除标准
- •1.Patients actively receiving therapy with strong CYP3A4 inhibitors and inducers and the treatment cannot be either discontinued or switched to a different medication at least 14 days prior to starting study drug.
- •2.Patients who are currently receiving treatment with any medications that have a known risk or possible risk to prolong the QT interval and the treatment cannot be either discontinued or switched to a different
- •medication prior to starting study drug. A list of QT prolonging compounds can be found at http://www.azcert.org/medical-pros/drug-lists/printable-drug-list.cfm.
- •3.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, mal-absorption, small bowel resection, or gastric bypass surgery).
- •4.Acute or chronic liver, pancreatic or severe renal disease considered unrelated to CML or ALL.
- •5.History of pancreatitis within 12 months of starting study drug or past medical history of chronic pancreatitis.
- •6.No active or systemic bacterial, fungal, or viral infection as
- •documented by positive cultures, radiological imaging techniques, or
- •septic shock syndrome.
- •7.Impaired cardiac function including any one of the following:
- •Inability to determine the QT interval on ECG
- •Complete left bundle branch block
- •Use of a ventricular-paced pacemaker
- •Congenital long QT syndrome or a known family history of long QT syndrome.
- •History of or presence of clinically significant ventricular or atrial tachyarrhythmias
- •Clinically significant resting brachycardia (<50 beats per minute)
- •QTc > 450 msec on baseline ECG (using the QTcF formula). If QTcF >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc
- •History of clinically documented myocardial infarction within 12 months of starting study drug.
- •History of unstable angina within 12 months of starting study drug.
- •Other clinically significant heart disease (e.g. congestive heart failure or uncontrolled hypertension).
- •8.Patients who have received dasatinib therapy within 3 days of starting study drug.
- •9.Patients who have received imatinib therapy within 5 days of starting study drug.
- •10.a)Patients who have received myelosuppressive chemotherapy within 14 days prior to first dose of study drug.
- •b)Patients who have not recovered from all acute toxicities from all prior myelosuppressive chemotherapy to = Grade 1 prior to starting study drug.
- •11. Patients receiving greater than 14 days of hydroxyurea for the treatment of Ph+ CML or corticosteroids for the treatment of Ph+ ALL and has not been discontinued at least one week after the initiation of nilotinib (see Section 6.6.4 for details on permitted concomitant use of hydroxyurea and corticosteroids).
- •12. a) Patients who have received hematopoietic growth factors within 7 days of starting study drug
- •b) Patients who have received Pegfligrastim (Neulasta®) within 14 days of starting study dru
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