CLINICAL TRIAL SUMMARY

MDACC Study No:2010-0991 (clinicaltrials.gov NCT No: NCT01371630)
Title:Phase I/II Study of the Combination of Inotuzumab Ozogamycin (CMC-544) with Low-intensity Chemotherapy in Patients with Acute Lymphoblastic Leukemia (ALL)
Principal Investigator:Hagop Kantarjian
Treatment Agent:6-mercaptopurine; ARA-C; Hyper-CVAD; Inotuzumab Ozogamicin; Methotrexate; Prednisone; Rituximab; Vincristine
Study Status:Open
Study Description:The goal of the Phase I part of this clinical research study is to test 2 dose
levels of the drug inotuzumab ozogamycin to find the highest tolerable dose
that can be given in combination with chemotherapy. The goal of Phase II is to
learn if inotuzumab ozogamycin given in combination with chemotherapy can help
to control ALL. The safety of the study drugs will also be studied.

Inotuzumab ozogamycin is designed to attach to a protein that is often found in
leukemia cells. This may cause the cancer cells to die.

Rituximab is designed to attach to cancer cells and damage them, which may
cause the cells to die.

Hyper-CVAD includes a combination of cyclophosphamide, vincristine,
dexamethasone, methotrexate, Ara-C (cytarabine), and Neulasta (pegfilgrastim).
The maintenance therapy used in this study is called POMP, which includes a
combination of mercaptopurine, methotrexate, vincristine, and prednisone.
These chemotherapy drugs are designed to interfere with the multiplication of
cancer cells, which may slow or stop their growth and spread throughout the
body. This may cause the cancer cells to die.

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Disease Group:Leukemia
Phase of Study:Phase I/Phase II
Treatment Agents:6-mercaptopurine
ARA-C
Hyper-CVAD
Inotuzumab Ozogamicin
Methotrexate
Prednisone
Rituximab
Vincristine
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:
Supported By:Pfizer
Return Visit:
Home Care:


Hide details for Study Contact InformationStudy Contact Information

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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