Study Evaluating the Efficacy of 90Yttrium-epratuzumab in Adults With CD22+ Relapsed/Refractory B-ALL

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2017
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.
Epistemonikos ID: 60fe0ea7611471e1d3314cdf0ae92f8ffad23030
First added on: May 17, 2024