EUCTR2010-018419-14-NL进行中（未招募）不适用
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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 14
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
- 性别
- All
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 as described in protocol
- •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 must have a negative serum pregnancy test within 7 days before initiation of study drug. Women of child-bearing potential, defined as all women physiologically capable and becoming pregnant, must use a highly effective method of contraception during dosing and for up to 7 days after last dose of study drug. Acceptable methods of birth control include total abstinence and male/female sterilization or a combination of any two of the following (a+b or a+c or b+c):
- •a. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormonal vaginal ring or transdermal hormone contraception.
- •b. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- •c. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel, cream, vaginal suppository.
- •7.Patients must have the following laboratory valu
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)
- •QTcF > 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 QTcF
- •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 (except alopecia) 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 drug.
- •13.Stem Cell Transplant (SCT) or Rescue without total body irradiation (TBI): Evidence of active graft vs. host disease, and < 3 months since SCT.
- •14.External beam radiation therapy (XRT):
- •< 2 weeks after local palliative XRT (small port)
- •< 3 months after prior total body irradiation, or craniospinal radiation,
- •or if = 50% radiation of pelvis was treated with radiation therapy
- •< 6 weeks after other substantial BM irradiation
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