20 November, 2018
Single-use technology, designed for the manufacturing of biopharmaceutical products, has made major inroads over the last 30 years. First introduced in the late 1970s in the form of disposable capsules and a ...
Inotuzumab Ozogamycin in Elderly Acute Lymphoblastic Leukemia (ALL) (NCT01371630)
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.
Last Editorial review: November 11, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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20 November, 2018
05 October, 2018
When the first antibody-drug conjugate (ADC) was approved by the U.S. Food and Drug Administration (FDA) in 2000, only a handful of patent applications claiming ADCs had been published. As research cont...