EUCTR2012-003101-10-DE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
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
- •Subjects must meet all of the following criteria:
- •1) Between the ages of = 6 months and < 18 years of age
- •2) Written informed consent and written informed assent (if applicable)
- •3) Must have histologically proven B-cell ALL with marrow involvement
- •4) Measurable or evaluable disease
- •5) Disease status:
- •Subjects must have relapsed or refractory disease and received at least 1 standard chemotherapy and either 1 salvage regimen or allogeneic HSCT.
- •In event of relapse after prior allogeneic HSCT, subjects must be at least 3 months post-transplant, have no evidence of active graft-vs-host disease, and been off immunosuppression for at least 4 weeks
- •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) status 1 or 2 are eligible only in the absence of neurologic symptoms, such as cranial nerve palsy, suggestive of CNS leukemia.
- •8) Female subjects of childbearing potential and post-pubertal male
- •subjects must agree to use an approved method of contraception for the study (if sexually active) or abstinence to meet eligibility criteria.
- •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
- •Any of the following would exclude the subject from participation in the study:
- •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, unless it is a non-interventional, observational study or the subject is in the follow-up period from a previous study, or prior sponsor approval is obtained
- •3) Employees of the study site directly involved with the conduct of the study at the site of proposed enrollment, or immediate family members of any such individuals
- •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) Laboratory findings or clinical evidence consistent with Grade = 3 disseminated intravascular coagulation (DIC) or any Grade 2 DIC that does not correct
- •10) Hyperleukocytosis (WBC = 50,000/µL) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy
- •11) Pregnant or breast-feeding females
- •12) A QTcF interval (manually overread) of = 481 msec (ie, = Grade 2) confirmed by medically qualified staff on at least 2 separate electrocardiograms (ECGs) performed at least 5 min apart within 28 days prior to enrollment
- •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 enrollment, 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) Other investigational antineoplastic agents within 30 days prior to Cycle 1, Dose of study treatment
- •17) Seropositivity for Human immunodeficiency virus (HIV)
- •18) Seropositivity for hepatitis B (HBsAg) or hepatitis C (HCV antibody)
- •19) Clinically significant ophthalmologic findings (evidence of retinal damage or injury) during the screening
- •20) 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
- •21) Presence of a second invasive malignancy
- •22) Any physical, social, or psychiatric condition, or any other condition which in the opinion of the principal investigator or designee would prevent effective study cooperation or participation in the study
- •23) Uncontrolled pulmonary infection, presence of pulmonary edema
- •24) Inadequate oxygen saturation
- •25) Serum albumin < 2 g/dL
- •26) Radioimmunotherapy within 2 years prior to enrollment in study
- •27) Subject with prior history of thrombotic microangiopathy or HUS.
- •28) Previous life-threatening anaphylactic reactions to prior monoclonal antibody-based immunotherapy or any component of the moxetumomab pasudotox formulation
- •29) T-cell ALL or T-cell lymphoblastic lymphoma
- •30) History of known congenital hypercoaguable condition
- •31) Subjects receiving high-dose estrogen therapy
- •32) For German Investigative Sites: Subjects with B-cell lymphoblastic lymphoma will be excluded.
研究者
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