NCT01371630 (Clinical Trial / Inotuzumab ozogamycin / CMC-544)

Study Title
Inotuzumab Ozogamycin in Elderly Acute Lymphoblastic Leukemia (ALL) (NCT01371630)

Trial Description
The goal of the Phase I part of this clinical research study is to test 2 dose levels of the drug inotuzumab ozogamycin (also known as CMC-544) 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.

This trial is sponsored by M.D. Anderson Cancer Center/Pfitzer. [1]

Study Data

Study Schematic 

NCT01371630 (Clinical Trial / Inotuzumab ozogamycin / CMC-544)

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Last Editorial review: November 11, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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