Spots Global Cancer Trial Database for Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia

Study Description

Brief Summary: To learn about the safety of post-HSCT two dose Inotuzumab Ozogamicin to participants with high risk B cell acute lymphoblastic leukemia(B-ALL). Also, to learn if giving Inotuzumab Ozogamicin to post-HSCT patients with high-risk B- ALL can help to reduce relapse and prolong disease free survival and overall survival.

Detailed Description: This is a Phase II study of inotuzumab ozogamicin for the treatment of patients who underwent transplantation for ALL and have a high risk of relapse. Participants will receive study treatment two doses until relapse of disease, unacceptable toxicity, or death, whichever occurs first Primary Objective • To assess the efficacy of inotuzumab ozogamicin as measured by disease free survival (DFS) at one year. Secondary Objective(s) * To evaluate relapse rate, nonrelapse mortality (NRM), relapse, relapse-related mortality and overall survival (OS) at 1 year. * To determine safety profile of inotuzumab ozogamicin after transplant including the incidence of hematological toxicity, secondary graft failure and other adverse event(AE)/severe adverse event(SAEs)

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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