EUCTR2010-024264-18-GB进行中（未招募）1 期
A Single-Arm Multicenter Phase II Study preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 93
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
入选标准
- •1. Morphologic and immunophenotypic evidence of B-precursor ALL (pro B-, pre B-, common ALL) with > 25% blasts in bone marrow (M3) at study enrolment.
- •2. Age < 18 years at enrollment [only children age 2-17 will be enrolled prior to the identification of the recommended Phase II dose].
- •3. Relapsed/refractory disease:
- •Second or later bone marrow relapse,
- •Any marrow relapse after allogeneic HSCT, or
- •Refractory to other treatments:
- •- Patients in first relapse must have failed to achieve a CR following full standard reinduction chemotherapy regimen of at least 4 weeks duration
- •- Patients who have not achieved a first remission must have failed a full standard induction regimen
- •4. Karnofsky performance status = 50% for patients = 16 years and Lansky Performance Status (LPS) of = 50% for patients < 16 years
- •5. Organ function requirements: Patients must have
- •a. Creatinine clearance = 70 mL/min/1.73 m2 or a normal serum creatinine based on age/gender prior to day 1
- •b. Adequate liver function defined as:
- •Total bilirubin = 1.5 x upper limit of normal (ULN) for age OR direct bilirubin = 1.5 mg/DL prior to day 1
- •ALT (SGPT) = 135 IU/L at least once during screening
- •6. Patient and/or his/her legal representative have reviewed the patient information/informed consent form and have had their questions answered and have given written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 70
- •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. Active acute or extensive chronic GvHD
- •2. Immunosuppressive agents to prevent or treat GvHD within 2 weeks prior to blinatumomab treatment
- •3. Evidence for current CNS involvement by ALL (CNS 2, CNS 3) or testicular involvement by ALL [patients with CNS relapse at the time of M3 relapse are not eligible for the Phase I part but are eligible for the Phase II part of the study, if CNS is successfully treated prior to enrollment]. Two successive CSF evaluations at least one week apart following completion of CNS therapy that are CNS1 are required
- •4. History of relevant CNS pathology or current relevant CNS pathology (seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)
- •5. History of autoimmune disease with potential CNS involvement or current autoimmune disease
- •6. Any HSCT within 3 months prior to blinatumomab treatment
- •7. Cancer chemotherapy within 2 weeks prior to blinatumomab treatment (except for intrathecal chemotherapy and/or low dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, glucocorticoids)
- •8. Chemotherapy related toxicities that haven’t resolved to = Grade 2
- •9. Radiotherapy within 2 weeks prior to blinatumomab treatment
- •10. Immunotherapy (e.g. rituximab, alemtuzumab) within 6 weeks prior to blinatumomab treatment
- •11. Any investigational product within 4 weeks prior to study entry
- •12. Previous treatment with blinatumomab
- •13. Known hypersensitivity to immune globulins or to any other component of the study drug formulation
- •14. Presence of HAMA reactivity (in patients with prior exposure to murine antibodies or proteins)
- •15. Active malignancy other than ALL
- •16. Symptoms and/or clinical signs and/or radiological and/or sonographic signs that indicate an acute or uncontrolled chronic infection, any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol
- •17. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive)
- •18. Pregnant or nursing female adolescent patients
- •19. Post-menarchal female adolescent patients or male adolescent patients not willing to use an effective form of contraception during treatment phase of the study and at least 3 months thereafter
- •20. Placed into an institution due to juridical or regulatory ruling
研究者
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