EUCTR2012-003101-10-NL进行中（未招募）不适用
A Phase 2, Multicenter, Single-arm Study of Moxetumomab Pasudotox in Pediatric Subjects with Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma of B-cell Origin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 76
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
- •Inclusion Criteria -
- •1) Between the ages of = 6 months and < 18 years of age
- •2) Written informed consent and written informed assent
- •3) Must have histologically proven B-cell ALL or B-cell lymphoblastic lymphoma with marrow involvement.
- •4) All subjects (both ALL and subjects with lymphoblastic lymphoma) must have M2 or M3 bone marrow classification.
- •5) Disease status:
- •a) Subjects must have relapsed or refractory disease
- •b) In the event of relapse after prior allogeneic HSCT, subjects must be at least 3 months post-transplant and have no evidence of active graft-vs-host disease, and must have been off immunosuppression for at least 4 weeks.
- •c) Must have resolution of the acute toxic effects to = Grade 2 from prior chemotherapy before entry, in the opinion of the investigator
- •6) Adequate Performance status.
- •7) Subjects with the following central nervous system (CNS 1 or 2) status are eligible only in the absence of neurologic symptoms
- •8) Female subjects of childbearing potential and post-pubertal male subjects must use an approved method of contraception for the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 76
- •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
- •Exclusion Criteria
- •1) Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- •2) Concurrent enrollment in another clinical study for cancer treatment, unless the subject is in the follow-up period from a previous study.
- •3) Employees of the study site directly involved with the conduct of the study at the site of proposed enrollment, or an immediate family member of any such individual
- •4) Isolated testicular or CNS ALL
- •5) Subjects with mixed-lineage leukemia (MLL) gene rearrangement
- •6) Inadequate Hepatic function
- •7) Inadequate Renal function
- •8) Radiologically-detected CNS lymphoma
- •9) Subjects with clear laboratory or clinical evidence of disseminated intravascular coagulation (DIC)
- •10) Hyperleukocytosis or rapidly progressive disease that would compromise ability to complete study therapy
- •11) A QTcF interval (manually overread) of = 481 milliseconds (ie, = Grade 2) that is confirmed by 2 additional separate electrocardiograms (ECGs) within 28 days prior to starting study drug. The initial screening ECG need not be repeated for confirmation if the QTcF interval (manual overread) is < 481 milliseconds.
- •12) Pregnant or breast-feeding females
- •13) Prior treatment with CAT-3888 (BL22), moxetumomab pasudotox, or any pseudomonas-exotoxin-containing compound
- •14) Prior treatment with any anticancer biologic therapy within 2 weeks prior to starting study drug , including but not limited to therapeutic monoclonal antibodies or antibody-drug conjugates.
- •15) Systemic chemotherapy = 2 weeks (6 weeks for nitrosoureas) and radiation therapy = 3 weeks prior to starting study drug with exceptions per protocol
- •16) Seropositivity for human immunodeficiency virus (HIV)
- •17) Seropositivity for hepatitis B (HBsAg) or hepatitis C (HCV antibody)
- •18) Clinically significant ophthalmologic findings (evidence of retinal damage or injury) during the screening
- •19) Uncontrolled, symptomatic, intercurrent illness including, but not limited to infection, congestive heart failure, cardiac arrhythmia, malaria infection or any other condition that would limit compliance with study requirements
- •20) Presence of a second invasive malignancy.
- •21)Any physical, social, or psychiatric condition, or any other condition which in the opinion of the Principal Investigator or designee would prevent effective cooperation or participation in the study
- •22) Uncontrolled pulmonary infection, presence of pulmonary edema
- •23) Inadequate Oxygen saturation
- •24) Serum albumin < 2 g/dL. Albumin infusions for correction of hypoalbuminemia are allowed, but cannot have been administered within 7 days prior to start of study drug.
- •25) Radioimmunotherapy within 2 years prior to start of study drug.
- •26) Subject with prior history of thrombotic microangiopathy or HUS.
- •27) T-cell ALL or T-cell lymphoblastic lymphoma
- •28) History of known congenital hypercoaguable condition
- •29) Previous life-threatening anaphylactic reactions to prior monoclonal antibody-based immunotherapy or any component of the moxetumomab pasudotox formulation
- •30) Subjects currently receiving high-dose estrogen therapy defined as >0.625mg/day of an estrogen compound or within 2 weeks prior to starting study drug.
研究者
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