Thu, 03 Oct 2013 02:00:00 GMT —
COLUMBIA (WACH) Chronic lymphocytic leukemia (CLL) is a type of cancer of the blood and bone marrow. The term "chronic" comes from the fact that it typically progresses more slowly than other types of leukemia and "lymphocytic" comes from the cells affected by the disease â?? a group of white blood cells called lymphocytes, which help your body fight infection. Many people with CLL have no early symptoms. Those who develop signs and symptoms may experience:
A new drug application has been submitted to the FDA for the investigational agent Ibrutinib as a therapy for previously treated chronic lymphocytic leukemia (CLL) and previously treated mantle cell lymphoma (MCL) after the positive results observed in two clinical trials, which showed high response rates to the drug. The filing for the indication for CLL was based on the results of a phase Ib/II trial, in which 85 patients with relapsed or refractory CLL or small lymphocytic lymphoma (SLL) received Ibrutinib orally once daily, with 51 patients receiving a 420 mg dose and 34 patients receiving an 840 mg dose.The overall response rate (ORR) in both treatment groups was 71%, with an additional 20% of patients in the 420 mg dose arm and 15% of patients in the 840 mg dose arm experiencing a partial response with lymphocytosis. After 26 months of follow-up, the estimated rate of progression-free survival (PFS) was 75%, and the rate of overall survival (OS) was 83% for all patients, irrespective of the dose. Side effects were minimal and consisted mostly of grade 1 or 2 transient diarrhea, fatigue, and upper respiratory tract infection.
- Enlarged, but painless, lymph nodes
- Pain in the upper left portion of the abdomen, which may be caused by an enlarged spleen
- Frequent infections