Clinical Trials > Haematology > CLL210 >> Information

Title

Phase II trial of alemtuzumab, dexamethasone and lenalidomide followed by randomisation to lenalidomide maintenance versus no further treatment for high-risk CLL (NCRI CLL210)

Basic Trial Information

Purpose

CLL210 is a new phase II trial of alemtuzumab, dexamethasone and lenalidomide for patients with high-risk CLL, defined as 17p- or early failure of fludarabine. Patients who respond to induction treatment and do not have an allogeneic transplant are randomised to lenalidomide maintenance versus no further treatment.

Rituximab containing chemo-immunotherapy has been shown to be ineffective in treating high risk CLL, and improving outcomes for affected patients is an important area of unmet clinical need.

A previous phase II study (CLL206) demonstrated that alemtuzumab-glucocorticoid combination therapy is effective in 17p- CLL, but improvement could be made in terms of response rates and toxicity. CLL210 will evaluate a new induction regimen that differs from CLL206 in three main respects:

- A third drug (lenalidomide - an oral agent with established activity in high-risk CLL) is included.

- The glucocorticoid regimen has been changed to pulsed oral dexamethasone, which contains a lower glucocorticoid dose than used in CLL206.

- Alemtuzumab will be given subcutaneously throughout.

Trial Lead Organisations

Official Title

Phase II trial of alemtuzumab, dexamethasone and lenalidomide followed by randomisation to lenalidomide maintenance versus no further treatment for high-risk CLL (NCRI CLL210)

Trial Start Date

23/01/2012

References

Trial Coordinator

James Dodd

Trial Coordinator Email Address

j.p.dodd@liv.ac.uk

Trial Coordinator Contact No

0151 795 5286