EUCTR2010-018419-14-IT进行中（未招募）不适用
A multi-center, open-label, pharmacokinetic study of oral nilotinib in pediatric patients with imatinib resistant / intolerant Ph+ CML chronic phase (CP) or accelerated phase (AP) or with refractory / relapsed Ph+ ALL - ND
适应症
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 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 the diagnosis of imatinib resistant or intolerant Ph+ CML CP or AP or Ph+ ALL either relapsed after or refractory to standard therapy. • Imatinib resistance in Ph+ CML is defined as: • Increasing WBC or platelet count while on imatinib therapy indicative of a hematological relapse or primary resistance to imatinib. • Cytogenetic or molecular response consistent with suboptimal response or failure criteria (Refer to Post-Text Supplement 2 for definition of suboptimal response). • Progression to accelerated phase or blast crisis while on imatinib therapy. • Reappearance of Ph+ bone marrow cells after a complete cytogenetic response to imatinib. • A greater than 30% increase in Ph+ cells on bone marrow cytogenetics while on imatinib therapy. • Loss of molecular response on imatinib therapy. • Imatinib intolerance (at any dose or duration) is defined as the development of AEs requiring discontinuation of imatinib therapy. 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 and if sexually active, must agree to use an effective method of contraceptive throughout study participation. 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:
- •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/printabledrug-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 disease. 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 hydroxyurea for Ph+ CML or corticosteroids for Ph+ ALL that has not been discontinued at least one week after the initiation of nilotinib. 12. a) Patients who have received hematopoietic growth factors within 7 days ofstarting 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. See protocol for the remaining criteria (14-19).
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