Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Cluster of Differentiation Antigen (CD22)-Positive Acute Lymphoblastic Leukemia
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 16 years and 75 years
Gender
Both males and females

Description

Primary Objective Phase I: To define a post hematopoietic stem cell transplantation maximum tolerated dose of inotuzumab Ozogamicin Phase II: To define the safety profile of inotuzumab Ozogamicin therapy after allogeneic transplant. Phase II: To determine the rate of veno-occlusive disease / sinusoi...

Primary Objective Phase I: To define a post hematopoietic stem cell transplantation maximum tolerated dose of inotuzumab Ozogamicin Phase II: To define the safety profile of inotuzumab Ozogamicin therapy after allogeneic transplant. Phase II: To determine the rate of veno-occlusive disease / sinusoidal obstruction syndrome (VOD/SOS). Secondary Objective(s) To evaluate non-relapse mortality (NRM), relapse, relapse-related mortality and overall survival (OS) at 1 year. To determine the incidence of myeloid toxicity and secondary graft failure. To determine if inotuzumab at these doses are effective at eradicating minimal residual disease (MRD) in this cohort of patients. Study Design This is a Phase I/II study of inotuzumab ozogamicin for the treatment of patients who underwent allogeneic transplantation for ALL and have a high risk of relapse. The Phase I portion of this study will be a 3/3 dose escalation trial with cohort expansion at the maximum tolerated dose (MTD). Subjects will receive study treatment until relapse of disease, unacceptable toxicity, 30 days after cycle 4, or death, whichever occurs first. Phase I: Inotuzumab Ozogamicin Dosing Escalation Subjects will be assessed for safety and tolerability (including adverse events, serious adverse events, and clinical/laboratory assessments) using a continuous monitoring approach. Phase II: Inotuzumab Ozogamicin Subjects will be assessed for safety and tolerability (including adverse events, serious adverse events, and clinical/laboratory assessments) using a continuous monitoring approach. In order to be included in the safety profile endpoint review, subjects must have received at least of 1 cycle of treatment.

Tracking Information

NCT #
NCT03104491
Collaborators
Not Provided
Investigators
Principal Investigator: Leland Metheny, MD University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center