©2022 Stanford Medicine
Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia
Trial ID: NCT01363297
The Phase 1 portion of this study will assess the safety, tolerability and efficacy at increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2 dose (RP2D) and schedule. The Phase 2 portion of the study will evaluate the efficacy of inotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients in second or later salvage status.
An Open-label, Phase 1/2 Study Of Inotuzumab Ozogamicin In Subjects With Relapsed Or Refractory Cd22-positive Acute Lymphocytic Leukemia
- Subjects with CD22-positive ALL with either refractory disease (i.e. disease
progression or no response while receiving their most recent prior anti-cancer
therapy), or relapsed disease (i.e. response to their most recent prior anti-cancer
therapy with subsequent relapse). Subjects enrolled in the Phase 2 portion of the
study must be due to receive salvage 2 or later therapy.
- Subjects with Philadelphia chromosome-positive (Ph+) ALL must have failed standard
treatment with at least one tyrosine kinase inhibitor.
- Adequate renal and hepatic function, and negative pregnancy test for women of
- Subjects with isolated extramedullary relapse or active central nervous system (CNS)
- Prior allogeneic hematopoietic stem cell transplant (HSCT) or other anti-CD22
immunotherapy within 4 months, or active graft versus host disease (GvHD) at study
- Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome
drug: Inotuzumab Ozogamicin
School of Medicine
300 Pasteur Drive
Stanford, CA 94305