Study Evaluating the Efficacy of 90Yttrium-epratuzumab in Adults With CD22+ Relapsed/Refractory B-ALL
Status:
Withdrawn
Trial end date:
2017-01-01
Target enrollment:
Participant gender:
Summary
The investigators propose a randomized phase 2 study evaluating 90Y-epratuzumab tetraxetan
for relapsed/refractory CD22+ B-ALL adult patients using the recommended activity of 370
MBq/m² x 2. in order to confirm the investigators' previous results. The cut-off of 70% for
the expression of CD22 has been chosen in order to propose this protocol to all adults with
CD22+ B ALL in relapse or with refractory disease. Indeed, median expression of CD22 is
almost 100% in this setting but some patients are documented between 70 and 100%. RIT will be
assessed in comparison with standard of care salvage chemotherapy regimens. Only three
standard salvage chemotherapy regimens will be permitted in order to avoid too much bias for
the comparative analysis of clinical efficacy.