Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427330
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-10
Brief Title:
Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia
Sponsor:
Institute of Hematology Blood Diseases Hospital China
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
Official Title:
Phase II Study Assessing the Efficacy and Safety of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of High Risk Acute Lymphoblastic Leukemia
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn about the safety of post-HSCT two dose Inotuzumab Ozogamicin to participants with high risk B cell acute lymphoblastic leukemiaB-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 Objectives
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 eventAEsevere adverse eventSAEs
To assess the efficacy of inotuzumab ozogamicin as measured by disease free survival DFS at one year
Secondary Objectives
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 eventAEsevere adverse eventSAEs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None