EUCTR2010-024264-18-Outside-EU/EEA进行中（未招募）不适用
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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
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. 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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