Inotuzumab ozogamicin in adults with relapsed or refractory CD22-positive acute lymphoblastic leukemia: a phase 1/2 study.

ABSTRACT: This study evaluated the safety, antitumor activity, pharmacokinetics, and pharmacodynamics of inotuzumab ozogamicin (InO) for CD22-positive relapsed/refractory acute lymphoblastic leukemia. In phase 1, patients received InO 1.2 (n = 3), 1.6 (n = 12), or 1.8 (n = 9) mg/m² per cycle on days 1, 8, and 15 over a 28-day cycle (≤6 cycles). The recommended phase 2 dose (RP2D) was confirmed (expansion cohort; n = 13); safety and activity of InO were assessed in patients receiving the RP2D in phase 2 (n = 35) and in all treated patients (n = 72). The RP2D was 1.8 mg/m² per cycle (0.8 mg/m² on day 1; 0.5 mg/m² on days 8 and 15), with reduction to 1.6 mg/m² per cycle after complete remission (CR) or CR with incomplete marrow recovery (CRi). Trea

SUBMITTER: DeAngelo DJ 

PROVIDER: S-EPMC5728308 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature