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A Phase 2 Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE Antibody Blinatumomab in Adult Subjects With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (Alcantara Study)
The primary objective is to evaluate the rate of complete remission/complete remission with partial hematological recovery (CRh\*) in adults with relapsed/refractory Philadelphia chromosome positive (Ph+) B-precursor acute lymphoblastic leukemia (ALL) who receive blinatumomab.
This is a single-arm Simon II stage design, multicenter study consisting of a screening period, an induction treatment period (2 cycles of blinatumomab), a consolidation treatment period (up to 3 additional cycles of blinatumomab for applicable participants), and a safety follow-up visit 30 days after treatment. Following the safety follow-up visit, participants will be followed for response duration and survival every 3 months for 18 months or death, whichever occurs first.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Research Site
Duarte, California, United States
Research Site
La Jolla, California, United States
Research Site
Atlanta, Georgia, United States
Research Site
Rochester, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
New York, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Houston, Texas, United States
Research Site
Nantes, France
Research Site
Paris, France
Start Date
January 3, 2014
Primary Completion Date
May 20, 2015
Completion Date
January 6, 2017
Last Updated
May 28, 2024
45
ACTUAL participants
Blinatumomab
DRUG
Lead Sponsor
Amgen
Data Source & Attribution
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