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Clinical Trials > Haematology

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CLL210 Phase II trial of ofatumumab, dexamethasone and lenalidomide for high-risk CLL (NCRI CLL210)

CLL210 is a new phase II trial of ofatumumab, 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 is replaced by an alternative monoclonal antibody, ofatumumab.

CLL210 originally used dexamethasone, lenalidomide and alemtuzumab in combination. In August 2012, Sanofi withdrew the licence for alemtuzumab as it was planned to market it for other indications. Because of difficulties in obtaining alemtuzumab suitable for trial use recruitment was suspended on 11 September 2012. Because of doubts about alemtuzumab's long term use in CLL, a decision was made to re-launch the study with alemtuzumab replaced by ofatumumab, an alternative monoclonal antibody. It is believed that ofatumumab will be as efficacious as alemtuzumab with reduced toxicity.
DESTINY A trial of de-escalation and stopping treatment in chronic myeloid leukaemia patients with excellent responses to tyrosine kinase inhibitor therapy (De-Escalation and Stopping Treatment of Imatinib, Nilotinib or sprYcel in chronic myeloid leukaemia)

The purpose of the study is to investigate whether some patients with excellent responses to chronic myeloid leukaemia (CML) are being over-treated and can remain well on a lower dose of treatment or without treatment at all.
PACIFICO Purine-Alkylator Combination In Follicular lymphoma Immuno-Chemotherapy for Older patients

Follicular lymphoma (FL) is the most frequently occurring type of indolent non-Hodgkin's lymphoma (NHL) in developed countries. The annual incidence is highest in patients aged 60 or over (1). The disease is usually widespread at presentation and is not curable with currently available treatments. The clinical course is one of recurrent remissions and relapses, the median survival being approximately 10 years from diagnosis

In the UK, R-CVP is approved by NICE for the first-line treatment of FL and is consequently regarded as the standard induction regimen for patients of all ages.

Older patients are almost certainly under-represented in clinical trials of FL owing to a trend for treatment regimens to become ever more intensive and because of the increasing stringency of inclusion criteria. Consequently, there is a lack of data concerning the optimal R-chemotherapy induction regimen in this patient group. The present study aims to remedy this situation by targeting patients with FL aged 60 or over.
RIAltO RIAltO: A Randomised Investigation of Alternative Ofatumumab-containing regimens in less fit patients with CLL


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