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A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
Not Recruiting
Trial ID: NCT01564784
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)
Stanford Investigator(s)
Michaela Liedtke
Associate Professor of Medicine (Hematology)
Eligibility
Inclusion Criteria:
- CD22 expression
- Adequate liver and renal functions
Exclusion Criteria:
- Isolated extramedullary disease
- Active Central Nervous System [CNS] disease
Intervention(s):
drug: inotuzumab ozogamicin
drug: FLAG (fludarabine, cytarabine and G-CSF)
drug: HIDAC (high dose cytarabine)
drug: cytarabine and mitoxantrone
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061