NL-OMON41557尚未招募2 期
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 - CD-ON-CAT8015-1036
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •Subjects must meet all of the following criteria:
- •1. Between the ages of >= 6 months and < 18 years of age at the time of screening
- •2. Written informed consent and written informed assent (if applicable) and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
- •3. Must have histologically proven B-cell ALL or B-cell lymphoblastic lymphoma with marrow involvement according to the French-American-British classification. NOTE: Subjects with extramedullary involvement outside of the CNS will not be excluded provided they have 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 and have received at least one standard chemotherapy and either one salvage regimen or allogeneic stem cell transplant.
- •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 Principal Investigator or designee
- •6. For non-leukemic subjects (ie, subjects with lymphoma), an ANC > 1,000/µL and platelet count > 50,000/mm2 are required, unless cytopenias are judged by the Principal Investigator or designee to be due to underlying disease (ie, potentially reversible with antineoplastic therapy). NOTE: There will be no WBC count, ANC, hemoglobin (Hgb), or platelet count requirement for enrollment of subjects with leukemia.
- •7. Performance status:
- •* For subjects >= 12 years of age, Eastern Cooperative Oncology Group (ECOG) score <= 2 (Appendix 2)
- •* For subjects < 12 years of age, Lansky scale >= 50% (Appendix 3)
- •* Subjects who are unable to walk, but who are upright in a wheel chair will be considered ambulatory (ECOG score >= 1 and <= 2, Lansky score >= 50% and <= 70%) for the purpose of calculating performance status (a conversion chart from ECOG, Karnofsky, and Lansky is located in Appendix 4).
- •8. Subjects with the following CNS status (CNS 1 or 2 as described below) are eligible only in the absence of neurologic symptoms, such as cranial nerve palsy, suggestive of CNS leukemia:
- •a. CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin preparation, regardless of the number of WBCs
- •b. CNS 2, defined as presence of < 5/µL WBCs in CSF and cytospin positive for blasts, or > 5/µL WBCs but negative by the Steinherz/Bleyer algorithm:
- •i. CNS 2a: < 10/µL red blood cells (RBCs); < 5/µL WBCs and cytospin positive for blasts
- •ii. CNS 2b: >= 10/µL RBCs; < 5/µL WBCs and cytospin positive for blasts
- •iii. CNS 2c: >= 10/µL RBCs; >= 5/µL WBCs and cytospin positive for blasts, but negative by Steinherz/Bleyer algorithm (Appendix 1).
- •9. With permission from the parents/legal guardian, as required by local regulations, study staff will discuss with female subjects of childbearing potential and post-pubertal male subjects the use of an approved method of contraception for the study. Sexually active subjects must agree to use an approved method of contraception (see Table 4.2.1-1) or
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) 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.
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