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临床试验/NL-OMON39198
NL-OMON39198已完成不适用

A multi-center, open-label, pharmacokinetic study of oral nilotinib in pedriatric patients with Gleevec (imatinib)-resistant/intolerant Ph+ CML chronic phase (CP) or accelerated phase (AP) or with refractory/relapsed Ph+ ALL.;Met protocol amendment #03 verandert de titel als volgt: *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 - AMN107A2120

ovartis0 个研究点目标入组 3 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
发起方
ovartis
入组人数
3
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

入排标准

年龄范围
2 至 17（—）

入选标准

  • •1. Male or female patients less than 18 years and more than 1 year of age at study entry.
  • •2. Patients must have one of the following: newly diagnosed CP Ph+ CML, CP or AP Ph+ CML resistant/-intolerant to imatinib and/or dasatinib, or Ph+ ALL either relapsed after or refractory to standard therapy.
  • •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 bone marrow cytogenetics while on
  • •imatinib or dasatinib therapy.
  • •Loss of molecular response on imatinib or dasatinib therapy.
  • •Imatinib/dasatinib intolerance (at any dose or duration) is defined as the development of AEs
  • •requiring discontinuation of imatinib or dasatinib therapy.
  • •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.
  • •3. Performance status: Karnofsky >= 50% for patients > 10 years of age, and Lansky >= 50 for
  • •patients <= 10 years of age.
  • •4. Patients must have adequate renal, hepatic and pancreatic function and normal electrolytes
  • •defined as:
  • •Creatinine clearance or radioisotope GFR >= 70 ml/min/1.73 m2, or
  • •a serum creatinine based on age as follows:
  • •Age (Years) Maximum Serum Creatinine (mg/dL)
  • •1 < age <= 5 0.8
  • •5 < age <= 10 1.0
  • •10< age <= 15 1.2
  • •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.
  • •5. 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

排除标准

  • •Patients meeting any of the following criteria will be excluded from entry into or continuation
  • •in the study:
  • •1. Patients actively receiving therapy with strong CYP3A4 inhibitors and the treatment
  • •cannot be either discontinued or switched to a different medication at least 14 days prior to starting study
  • •2. Patients who are currently receiving treatment with any medications that have a known
  • •risk or potential risk to prolong the QT interval and the treatment cannot be either
  • •discontinued or switched to a different medication prior to starting study drug.
  • •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 study entry 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 study
  • •History of unstable angina within 12 months of study entry
  • •Other clinically significant heart disease (e.g. congestive heart failure or uncontrolled
  • •hypertension).
  • •8. Patients who have received dasatinib therapy within the past 3 days.
  • •9. Patients who have received imatinib therapy within the past 5 days.
  • •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
  • •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 prior to initiation of nilotinib (see section 6.6.4 for details on permitted concomitant use of hydroxyurea and corticosteroids).
  • •12. Patients who have received hematopoietic growth factors within 7 days of study start or
  • •Pegfilgrastim (Neulasta®) within 14 days of study start.
  • •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 >= 50%
  • •radiation of pelvis

研究者

发起方
ovartis

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