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

Service: Trial Number:
124-12
Principal Investigator: Conducted at:
Miller Children's & Women's Hospital Long Beach
Currently enrolling additional patients:
Yes
Age Range:
0-6 years; 7-17 years
Gender:
Male & Female

This study is being carried out to determine the effectiveness and safety of moxetumomab pasudotox in treating relapsed (tumor has come back after being treated) or refractory (has not gone away with previous treatment) pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma of B-cell origin. Moxetumomab pasudotox is an experimental drug that can be used to treat relapsed or refractory B-cell pALL or B-cell Lymphoblastic Lymphoma. “Experimental” means the drug has not been approved by any Authority that regulates new medicines such as the United States Food and Drug Administration (FDA). In laboratory experiments, moxetumomab pasudotox has been shown to kill leukemia cells that have the CD22 protein on their surface and to decrease tumors in mice. CD22 is a protein from the immune system which can be found on the surface of cancer cells. We hope this study will show that moxetumomab pasudotox can work in humans to kill cancer cells especially those cells that have CD22.