Phase 1/2a study of ABT-263 in Chronic Lymphocytic Leukaemia
Research type
Research Study
Full title
A Phase 1/2a study evaluating the safety, pharmacokinetics, and efficacy of ABT-263 in subjects with relapsed or refractory chronic lymphocytic leukaemia.
IRAS ID
3779
Sponsor organisation
Abbott GmbH & Co. KG
Eudract number
2007-002143-25
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Chronic Lymphocytic Leukaemia(CLL) is a cancer of the white blood cells. It is the most common type ofleukaemia. CLL is not considered to be curable at the moment, although thereare treatments that are successful in getting many people into remission.ABT-263 is a potential treatment for CLL, which has been shown in laboratoryexperiments to help kill human cancer cells. It does this by balancing theproteins which ensure that cells are killed off when they need to be, as thesecan stop working normally in patients with cancer. ABT-263 has been given to less than 100people with cancer so far and is in the early stages of clinical testing. Thisstudy will explore the safety of ABT-263 when it is given to patients with CLLand see what the maximum dose is that a person can tolerate. It will alsoinclude an initial assessment of whether the drug helps patients with this typeof cancer. This is an open-label study, which means that everyone who enrols istreated with ABT-263. It is not certain that patients in this study willbenefit from taking ABT-263. Information from the study may help provide peoplesuffering from CLL with a better treatment in the future. Patients will attendhospital for visits throughout the study; these will be most frequent duringthe first cycle of treatment. At these visits they will undergo assessments tocheck on their safety and see how the drug is working. These assessments willinclude blood tests, physical examinations, scans and taking a bone marrow sample.Patients will continue to take ABT-263 for up to 1 year after the last patientstarts the study, as long as their doctor feels they are clinically benefitingand coping with any side effects.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
08/H0406/171
Date of REC Opinion
11 Nov 2008
REC opinion
Further Information Favourable Opinion