Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-17-048
Prinicipal Investigator
McGregor, Lisa
Phase
Phase II
Age Group
Both
Scope
National
Secondary Protocol No.
AALL1621
Title
A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518) in Children and Young Adults With Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)
Objective
Primary Aim
To determine the morphologic response rate (complete response [CR] + complete response with incomplete hematologic recovery [CRi]) following one cycle of treatment with InO in children with relapsed or refractory CD22+ B-ALL.
Secondary Aims
To determine the CR/CRi rate following 2 cycles of InO therapy.
To determine the safety of single agent InO administered at the adult recommended phase 2 dose (RP2D) to pediatric patients with relapsed or refractory CD22+ B-ALL.
To determine the level of minimal residual disease (MRD) by flow cytometry in responding patients.
To determine the incidence, severity, and outcomes of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver in patients during InO therapy and following subsequent treatment, including myeloablative hematopoietic stem cell transplantation (HSCT).
To estimate the 3-year event-free survival (EFS), 3-year overall survival (OS), and among responders, duration of CR/CRi for pediatric patients with relapsed or refractory B-ALL treated with InO.
Applicable Disease Sites
Lymphoid Leukemia
Status
Open
Participating Institutions
Hershey Medical Center