CLINICAL TRIAL SUMMARY

MDACC Study No:2012-0151 (clinicaltrials.gov NCT No: NCT01564784)
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)
Principal Investigator:Hagop Kantarjian
Treatment Agent:Cytarabine; Fludarabine; G-CSF; Inotuzumab Ozogamicin; Mitoxantrone
Study Status:Open
Study Description:The goal of this clinical research study is to compare inotuzumab ozogamicin to
3 other types of chemotherapy treatments when given to patients with relapsed
or refractory ALL. The safety of inotuzumab ozogamicin will also be studied.

Inotuzumab ozogamicin is designed to attach to a protein that is often found in
leukemia cells. This will allow the drug to go inside the cell and may cause
the cancer cells to die.

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Disease Group:Leukemia
Phase of Study:Phase III
Treatment Agents:Cytarabine
Fludarabine
G-CSF
Inotuzumab Ozogamicin
Mitoxantrone
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:Pfizer
Return Visit:
Home Care:


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Physician Name:Hagop Kantarjian
Dept:Leukemia
For Clinical Trial Enrollment:713-792-7026
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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