EUCTR2018-002619-89-ES进行中（未招募）1 期
A SINGLE ARM, OPEN-LABEL, PHASE 4 STUDY EVALUATING QT INTERVAL, PHARMACOKINETICS, AND SAFETY OF GEMTUZUMAB OZOGAMICIN (MYLOTARG™) AS A SINGLE-AGENT REGIMEN IN PATIENTS WITH RELAPSED OR REFRACTORY CD33-POSITIVE ACUTE MYELOID LEUKEMIA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 51
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. Refractory or relapsed (ie, bone marrow blasts =5%) CD33-positive AML.
- •2. Age=12 years.
- •3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.
- •4. Initial peripheral white blood cells (WBC) counts <30,000/ µL;
- •patients with a higher WBC count should undergo cytoreduction.
- •5. Adequate renal/hepatic functions, ie:
- •- Serum creatinine =1.5 x upper limit of normal (ULN) or any serum
- •creatinine level associated with a measured or calculated creatinine
- •clearance of =40 mL/min;
- •- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
- •<2.5×ULN; total bilirubin <2×ULN.
- •6. Negative serum or urine pregnancy (human chorionic gonadotropin
- •[hCG]) test within 1 week before treatment for women of child bearing
- •7. Evidence of a personally signed and dated informed consent document
- •and obtaining proper pediatric assent in addition to consent according to
- •local regulations (by the caregivers or legally acceptable representative
- •[eg, parents] in the pediatric patients) indicating that the patient [or a legally acceptable representative/parent(s)/legal guardian] has been informed of all pertinent aspects of the study.
- •8. Willing and able to comply with scheduled visits, treatment plan,
- •laboratory tests, and other study procedures.
- •9. Female patients of non-childbearing potential must meet at least 1 of
- •the following criteria:
- •- Achieved postmenopausal status, defined as follows: cessation of
- •regular menses for at least 12 consecutive months with no alternative
- •pathological or physiological cause; status may be confirmed with a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
- •- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- •- Have medically confirmed ovarian failure.
- •All other female patients (including female patients with tubal ligations) are considered to be of childbearing potential.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 6
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Patients with prior treatment with GO.
- •2. Patients with prior history of VOD/SOS.
- •3. Prior HSCT is not allowed, if it was conducted within 2 months prior to
- •study enrollment.
- •4. Patients with known active central nervous system (CNS) leukemia.
- •5. Uncontrolled or active infectious status.
- •6. Any of the following within the 3 months prior to starting study
- •treatment: myocardial infarction, severe/unstable angina,
- •coronary/peripheral artery bypass graft, congestive heart failure, or
- •cerebrovascular accident including transient ischemic attack, or
- •symptomatic pulmonary embolism.
- •7. Uncontrolled cardiac dysrhythmias of NCI CTCAE Grade 2,
- •uncontrolled atrial fibrillation of any grade.
- •8. Sero-positivity to human immunodeficieny virus (HIV).
- •9. Active hepatitis B or hepatitis C infection (see Appendix 2 of the protocol).
- •10. Chemotherapy, radiotherapy, or other anti-cancer therapy (except
- •hydroxyurea as cytoreduction) within 2 weeks prior to enrollment in the
- •11. Major surgery within 4 weeks prior to enrollment.
- •12. Diagnosis of any other malignancy within 3 years prior to enrollment,
- •except for adequately treated basal cell or squamous cell skin cancer, or
- •carcinoma in situ of the cervix.
- •13. QTc interval >470 milliseconds (msec) using the Fridericia (QTcF)
- •(based on the mean value of the triplicate electrocardiograms [ECGs]),
- •family or personal history of long or short QT syndrome, Brugada
- •syndrome or known history of QTc prolongation, or Torsade de Pointes
- •14. The use of medications known to predispose to Torsades de Pointes
- •within 2 weeks prior to enrollment (see Appendix 4 of the protocol).
- •15. History of allergic reactions attributed to compounds of similar
- •chemical or biologic composition to GO.
- •16. Investigator site staff members directly involved in the conduct of
- •the study and their family members, site staff members otherwise
- •supervised by the investigator, or patients who are Pfizer employees,
- •including their family members, directly involved in the conduct of the
- •17. Participation in other studies involving investigational drug(s) within
- •2 weeks prior to study entry and/or during study participation.
- •18. Other acute or chronic medical or psychiatric condition including
- •recent (within the past year) or active suicidal ideation or behavior or
- •laboratory abnormality that may increase the risk associated with study
- •participation or investigational product administration or may interfere
- •with the interpretation of study results and, in the judgment of the
- •investigator, would make the patient inappropriate for entry into this
- •19. Pregnant female patients; breastfeeding female patients; fertile male
- •patients and female patients of childbearing potential who are unwilling
- •or unable to use 2 highly effective methods of contraception as outlined
- •in this protocol for the duration of the study and for 7 months after the
- •last dose of investigational product.
研究者
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