Overview

A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia

Status:
Completed
Trial end date:
2017-01-04
Target enrollment:
0
Participant gender:
All
Summary
This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Collaborator:
UCB Pharma
Treatments:
Cytarabine
Fludarabine
Fludarabine phosphate
Inotuzumab Ozogamicin
Mitoxantrone
Criteria
Inclusion Criteria:

- CD22 expression

- Adequate liver and renal functions

Exclusion Criteria:

- Isolated extramedullary disease

- Active Central Nervous System [CNS] disease