Phase 2 Trial of Blinatumomab in Philadelphia Positive/BCR-ABL Positive Acute Lymphoblastic Leukemia

This study seeks adult subjects with R/R Ph+ B-precursor ALL. 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 subjects), and a safety follow-up visit 30 days after treatment. Following the safety follow-up visit, subjects will be followed for response duration and survival every 3 months for 18 months or death, whichever occurs first.


Study Type: Interventional
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)
Enrollment: 45
Study Start Date: December 2013
Estimated Study Completion Date: February 2017
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Blinatumomab