Rediatric Subjects with Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma of B-cell Origin MedDRA version: 17.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864 MedDRA version: 17.0 Level: LLT Classification code 10003939 Term: B-lymphoblastic lymphoma (Kiel Classification) System Organ Class: 100000004864
Conditions
Interventions
Product Name: Moxetumomab Pasudotox
Product Code: CAT-8015
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Moxetumomab Pasudotox
CAS Number: 1020748-57-5
Current Sponsor code: CAT-8015
Sponsors
MedImmune, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria - 1) Between the ages of = 6 months and 1000/µL, and platelet count > 50,000/mm2 are required. 7) Adequate Performance status. 8) Subjects with the following central nervous system (CNS) status 1 or 2 are eligible only in the absence of neurologic symptoms. 9) 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
Exclusion criteria
Exclusion criteria: 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, 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 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 greater than or equal to a Grade 2 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 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 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 study cooperation or participation in the study 22) Uncontrolled pulmonary infection, presence of pulmonary edema 23) Inadequate oxygen saturation 24) Serum albumin < 2 g/dL 25) Radioimmunotherapy within 2 years prior to study enrollment in study 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 receiving high-dose estrogen therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the efficacy defined as Composite Complete Response (CRc);Primary end point(s): Assess the efficacy defined as composite complete response (CRc);Timepoint(s) of evaluation of this end point: Disease assessments will be completed prior to the first cycle and subsequent cycles;Secondary Objective: • Assess safety and tolerability • Assess immunogenicity and pharmacokinetics • Progression-free survival (PFS), overall survival (OS), Duration of complete response (DOCR), Duration of overall response (DOR) • Minimal residual disease negative CRc rate • Number eligible for stem cell transplant • Overall response rate (ORR) • Hematologic activity | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Assess safety and tolerability • Assess immunogenicity and pharmacokinetics • PFS, OS, DOCR, DOR • Minimal residual disease negative CRc rate • Number eligible for stem cell transplant • ORR • Hematologic activity;Timepoint(s) of evaluation of this end point: Duration of study | — |
Countries
Australia, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Enquiries
MedImmune, LLC
Outcome results
None listed