RORCLL 009
Research type
Research Study
Full title
A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY OF THE SAFETY AND EFFICACY OF DIFFERENT LENALIDOMIDE (REVLIMID®) DOSE REGIMENS IN SUBJECTS WITH RELAPSED OR REFRACTORY B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA
IRAS ID
28968
Contact name
Peter Hillmen
Eudract number
2009-009836-54
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to test the safety and effectiveness of different dose levels of lenalidomide in patients with relapsed or refractory B-Cell Chronic Lymphocytic Leukemia (CLL). Chronic Lymphocytic Leukemia (CLL), the most common type of Leukemia, affects a particular lymphocyte, the B cell, which starts in the bone marrow, develops in the lymph nodes, and normally fights infection. In CLL, the DNA of a B cell is damaged, so that it can't fight infection, but it grows out of control (to become a cancer) and crowds out the healthy blood cells that can fight infection. While generally considered incurable, CLL progresses slowly in most cases. CLL treatment focuses on controlling the disease and its symptoms rather than on an outright cure. Lenalidomide is a potential treatment for CLL. Lenalidomide has been used to successfully treat both inflammatory disorders and cancers in the past 10 years. Lenalidomide has the ability to inhibit the growth of multiple myeloma cells and can cause cell death. It is thought to do this by blocking the development of new blood vessels. Cancer cells need to make new blood vessels so they can grow and spread. By preventing the growth of these new blood vessels lenalidomide cuts off the supply of nutrients to any growing tumors. It also has been shown to have various effects on the immune system which may contribute to its therapeutic effect. There are other treatments available for CLL but there is also a need to develop more active treatments to cater toward each individual patient and improve their outcome.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
09/H0206/45
Date of REC Opinion
20 Nov 2009
REC opinion
Further Information Favourable Opinion