A pilot study to establish the safety and efficacy of a combination of dexamethasone and lenalidomide in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) - LenD (Lenalidomide in CLL)

niversity College London0 sites12 target enrollmentJanuary 4, 2012

Overview

No summary available.

Registry

who.int

Start Date

January 4, 2012

End Date

February 1, 2016

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

niversity College London

•1\. Diagnosis of relapsed or refractory CLL as defined by the NCIWG criteria, requiring treatment
•2\. 1\-3 lines of prior therapy
•3\. Fludarabine\-based therapy inappropriate
•4\. Alemtuzumab\-based therapy inappropriate
•5\. WHO Performance status \=2
•6\. Age \= 18 years
•7\. Life expectancy \> 6 months
•8\. Male and female subjects must meet the inclusion criteria for the Lenalidomide Pregnancy Risk Minimisation Plan (or must meet the criteria for women of non\-child\-bearing potential).
•9\. Male and female subjects (except women meeting the criteria of non\-child\-bearing potential) must agree to follow the Lenalidomide Pregnancy Risk Minimisation Plan(including contraception 4 weeks before, during and 4 weeks after treatment for females of child\-bearing potential).
•10\. Signed written informed consent

•1\. Previously untreated CLL
•2\. Fit patients for whom alemtuzumab or fludarabine\-based therapy would be appropriate
•3\. Creatinine clearance \< 30ml/min calculated by Cockcroft\-Gault
•4\. Bilirubin \> 1\.5 x upper limit of normal
•5\. Patients with marrow suppression resulting in significant cytopenia (Neutrophils \<0\.5 x 10^9/l, Platelets \<30 x 10^9/l).
•6\. Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy or other investigational therapy within 4 weeks prior to study Day 1\.
•7\. Known infection with HIV, hepatitis B or hepatitis C.
•8\. Uncontrolled glaucoma, diabetes mellitus, hypertension or symptomatic peptic ulcer disease
•9\. Peripheral neuropathy \> grade 1
•10\. Proven or suspected transformation to aggressive B\-cell malignancy (e.g. large B\-cell lymphoma, Richter’s syndrome, or PLL).