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Clinical Trial to Test Leukemia Drug Combination [UPDATED]

Diffuse large B-cell lymphoma (NIH)

Diffuse large B-cell lymphoma (NIH)

UPDATE, 29 December 2011: Emergent Biosolutions, Abbott Labs End Collaboration

Emergent BioSolutions Inc. in Rockville, Maryland has started a phase 2 clinical study of its drug candidate TRU-016 in combination with the chemotherapy drug bendamustine for patients with relapsed chronic lymphocytic leukemia (CLL). The company is developing TRU-016 in a partnership with Abbott Laboratories.

Chronic lymphocytic leukemia is a type of cancer that causes a slow increase in white blood cells called B lymphocytes, or B cells. Cancerous cells spread from the blood marrow to the blood, and can also affect the lymph nodes or other organs, and eventually cause the bone marrow to fail.

Emergent developed TRU-016 to treat B-cell malignancies, such as CLL. According to the company, preclinical research has shown TRU-016 to have anti-tumor therapeutic potential, both alone and in combination with bendamustine, a drug already approved for the treatment of CLL and non-Hodgkin lymphoma. A phase 1b trial determined tolerable doses for TRU-016.

The phase 2 trial will test the safety and efficacy of TRU-016 in combination with bendamustine compared with bendamustine alone in a total of some 100 randomized patients, divided equally between test and control groups. The subjects will be relapsed CLL adult (age 18 or older) patients with one to three prior treatments, but no prior bendamustine treatments.

Responses of patients to the therapies will be measured against guidelines developed by the 2008 International Workshop on Chronic Lymphocytic Leukemia and 1996 National Cancer Institute criteria. These guidelines and criteria include progression-free survival, duration of response, and improvement in quality of life and disease symptoms.

Read more: Treatment Developed for Immune Systems of Chemo Patients

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