Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia.

ABSTRACT:

Background

The prognosis for adults with relapsed acute lymphoblastic leukemia is poor. We sought to determine whether inotuzumab ozogamicin, an anti-CD22 antibody conjugated to calicheamicin, results in better outcomes in patients with relapsed or refractory acute lymphoblastic leukemia than does standard therapy.

Methods

In this phase 3 trial, we randomly assigned adults with relapsed or refractory acute lymphoblastic leukemia to receive either inotuzumab ozogamicin (inotuzumab ozogamicin group) or standard intensive chemotherapy (standard-therapy group). The primary end points were complete remission (including complete remission with incomplete hematologic recovery) and overall survival.

Results

Of the 326 patients who underwent randomization, the first 218 (109 i

SUBMITTER: Kantarjian HM 

PROVIDER: S-EPMC5594743 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature