ASH News Daily 2013 - Day 2 - (Page B-31)

NoW eNRolliNG Acute lymphoblAstic leukemiA INO-VATE ALL iNotuzumab ozogamicin trial to inVestigAte tolerability and efficacy A randomized, phase 3 trial in patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL) This is a 2-armed, randomized, open-label, phase 3 study designed to evaluate the hematologic remission rate (CR + CRi) with inotuzumab ozogamicin compared with investigators' choice of FLAG, cytarabine combined with mitoxantrone, or HIDAC. Selected inclusion criteria * Relapsed or refractory CD22-positive ALL due to receive salvage 1 or salvage 2 therapy * Ph+ ALL patients must have failed treatment with at least 1 second-generation tyrosine kinase inhibitor * Bone marrow involvement with ≥5% lymphoblasts * Aged 18 years or older * ECOG performance status 0-2 * Adequate liver function Selected exclusion criteria * Isolated extramedullary relapse, Burkitt's lymphoma or mixed-lineage leukemia, or active central nervous system leukemia * Active heart disease * Prior chemotherapy ≤2 weeks prior to randomization and/or patients not recovered from acute toxicity * Prior treatment with monoclonal antibodies ≤6 weeks before randomization * Prior allogeneic hematopoietic stem cell transplant ≤4 months before randomization * Peripheral lymphoblasts >10,000/μL Reference: ClinicalTrials.gov Web site. http://clinicaltrials.gov/ct2/show/NCT01564784. Accessed April 3, 2012. inotuzumab ozogamicin is an investigational compound. This information is current as of August 14, 2012. STW00067B © 2012 Pfizer Inc. All rights reserved. April 2012 learn more about iNo-VAte (b1931022) For more information about this trial, please visit www.clinicaltrials.gov (Nct01564784) or call: 1-877-369-9753 in the united states and canada (toll-free) or +1-646-277-4066 outside the united states 

Table of Contents for the Digital Edition of ASH News Daily 2013 - Day 2

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ASH News Daily 2013 - Day 2

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