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
A study for children with pediatric acute Lymphoblastic Leukemia using study drug Moxetumomab Pasudotox
Sponsor: MedImmune LLC
Enrolling: Male and Female Patients
IRB Number: AAAO2150
U.S. Govt. ID: NCT02227108
Contact: Maria Sulis: 212 305 9770 / mls95@columbia.edu
Additional Study Information: The purpose of this study is to determine the effectiveness and safety of the study drug moxetumomab pasudotox in treating children with relapsed or refractory pALL or Lymphoblastic Lymphoma of B-cell origin. Moxetumomab pasudotox is made up of two parts: 1) a modified mouse antibody that attaches to a protein from the immune system, called CD22, which can be found on the surface of cancer cells, and 2) a toxin (a type of poison). An antibody is a type of protein that your/your childs immune system makes when it sees a foreign substance in your/your childs body. The modified mouse antibody used in moxetumomab pasudotox has been changed in the laboratory to contain only the part that attaches to CD22. The second part of moxetumomab pasudotox is a toxin that is made by bacteria. Moxetumomab pasudotox is made by combining the portion of the antibody that attaches to CD22 with the toxin. Inlaboratory experiments, moxetumomab pasudotox has been shown to kill leukemia cells that have the CD22 protein on their surface and to decrease tumors in mice. We hope this study will show that moxetumomab pasudotox can work in humans to kill cancer cells especially those cells that have CD22 on their surface.
This study is closed
Investigator
Maria Sulis, MD
Do You Qualify?
Does your child have a confirmed diagnosis of lymphoblastic B-cell ALL (Acute Lymphoblastic Leukemia)? Yes No
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For more information, please contact:
Maria Sulis
mls95@columbia.edu
212 305 9770