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An Open-label, Randomized Phase III Study of Inotuzumab Ozogamicin Compared to a Defined Investigator's Choice in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL)

Conditions

Leukemia, other

Trial Phase

Phase III

Trial Purpose and Description

Trial Purpose

This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.


Participation Guidelines

Age:
Gender:
Both

Eligibility Criteria

Criteria

Inclusion Criteria:

  • CD22 expression
  • Adequate liver and renal functions

Exclusion Criteria:

  • Isolated extramedullary disease
  • Active Central Nervous System [CNS] disease
Sponsor:
Pfizer Inc., U.S. Pharmaceuticals Group
Dates:
08/20/2013
Last Updated:
Study HIC#:
1301011417