Trials for patients with early stage CLL approved by the British NCRI
RESPECT – (CLL203)
This is a 40 patient single arm study to investigate the use of Lenalidomide in patients with early stage CLL with 2 or more poor prognostic factors. Christie Hospital is managing the trial. There are stringent stopping rules. Screening conducted by HMDS in Leeds. Biobanking samples will be collected from all screened patients.
The trial opened and recruited 2 pts but recruitment is currently suspended following the release of 2nd malignancy data following the use of Lenalidomide. Recruitment had been slow prior to suspension of recruitment. It was asked whether the group if they were still interested in the trial and whether the design was still viable. These issues were discussed by the group; problems include: there is limited data on the use of this toxic treatment (lenalidomide) in patients who may otherwise not require treatment; the variable rate of progression of Stage A patients, even those with a poor prognosis and many stage A are treated in DGHs. However, it is still an interesting question. To wait for official feedback from Celgene before assessing the full impact on the protocol, the risk-benefit analysis and the re-opening the study.