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
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

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