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临床试验/EUCTR2010-018419-14-DE
EUCTR2010-018419-14-DE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.

ovartis Pharma Services AG0 个研究点目标入组 14 人开始时间: 2010年12月29日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
14
研究概览入排标准研究者记录与标识符相似试验

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
  • •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 to the first dose of study medication):
  • •Potassium = LLN
  • •Magnesium = LLN
  • •Phosphorus = LLN
  • •Total calcium (corrected for serum albumin) = LLN
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 14
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

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 prior to starting study drug.
  • •9.Patients who have received imatinib therapy within 5 days prior to 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 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
  • •< 6 weeks after other substantial BM irradiation
  • •15.Patients

研究者

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