Study identifier:CD-ON-CAT-8015-1036
ClinicalTrials.gov identifier:NCT02227108
EudraCT identifier:N/A
CTIS identifier:N/A
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
B-Cell Pediatric ALL
Phase 2
No
Moxetumomab Pasudotox
All
37
Interventional
6 Months - 18 Years
Allocation: N/A
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Mar 2017 by MedImmune, LLC
MedImmune, LLC
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The primary objective of this study is to evaluate the efficacy of moxetumomab pasudotox in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) or B-cell lymphoblastic lymphoma.
This is a global, multicenter, open-label, single-arm Phase 2 study to evaluate the efficacy and safety of moxetumomab pasudotox monotherapy in pediatric participants with relapsed or refractory B-cell ALL or B-cell lymphoblastic lymphoma. Participants will be enrolled at sites in North America, Europe, and Australia. This is an approximate 35 month study.
Location
Location
Los Angeles, CA, United States
Location
Bethesda, MD, United States
Location
Seattle, WA, United States
Location
Durham, NC, United States
Location
New York, NY, United States
Location
Columbus, OH, United States
Location
Parkville, Australia
Location
Chicago, IL, United States
Arms | Assigned Interventions |
---|---|
Experimental: Moxetumomab Pasudotox 40 mcg/kg Participants received 6 doses of moxetumomab pasudotox 40 microgram per kilogram (mcg/kg) intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy. | Drug: Moxetumomab Pasudotox Participants received 6 doses of moxetumomab pasudotox 40 microgram per kilogram (mcg/kg) intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy. Other Name: CAT-8015 |
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