At a glance
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Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab
In Brief
A Phase 2 clinical trial evaluating Blinatumomab, Inotuzumab Ozogamicin, and 2 other interventions for Relapsed/Refractory and B-cell Acute Lymphocytic Leukemia. Currently recruiting, targeting 40 participants across 1 site.
Detailed Summary
To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsed/refractory B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD. Also, to learn if giving brexucabtagene autoleucel to patients with relapsed/refractory or high-risk, newly diagnosed B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD can help to control the disease.
Study Details
Timeline
Interventions
Given by Infusion
Given by IV
Given by IV Participants younger than 60 years of age, you will receive hyper-CVAD.
Given by IV Participants 60 years of age or older, you will receive mini-hyper-CVD