Saturday, November 19, 2011

What happened to the Respect Trial?

Trials for patients with early stage CLL approved by the British NCRI

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.

Current Status

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.


Anonymous said...

As new therapies are developed in medicine there are often dramatic differences of opinion re the risks & benefits.

Dr. Kahn certainly is entitled to his opinions. I recently consulted 2 well known & well respected CLL specialists to map out where Zi should " go next" as my disease is on the move.

Without prompting, the first told me that lenalidomide was not a good choice in patients with CLL mainly because it is so difficult to get a large enough dose safely and tolerably into CLL patients. The second specialist never evenentionex it as an option.

I suspect that I would have gotten different advice in Buffalo, NY.

Anonymous said...

Thank you for the update

Anonymous said...

Whatpercent of pateints taking lenalidomide go on to develop a seconday cancer? It must be a very small number.

Terry Hamblin said...

Very small. There are no valid figures. More likely these weresecondary to CLL, not its treatment.