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

Trial ID or NCT#

NCT01564784

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

AN OPEN-LABEL, RANDOMIZED PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN COMPARED TO A DEFINED INVESTIGATOR'S CHOICE IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - CD22 expression - Adequate liver and renal functions
Exclusion Criteria:
  1. - Isolated extramedullary disease - Active Central Nervous System [CNS] disease

Investigator(s)

Michaela Liedtke
Michaela Liedtke
Hematologist-Oncologist
Associate Professor of Medicine (Hematology)

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Contact

CCTO
650-498-7061