Pilot Study to Establish Safety & Efficacy of a Combination of Dexamethasone and Lenalidomide in Patients With Relapsed or Refractory Chronic Lymphocytic Leukaemia (CLL)

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to establish the safety and efficacy of a combination of dexamethasone and lenalidomide (Revlimid®) (D+L) in subjects with relapsed or refractory CLL who have failed or are unable to tolerate standard up-front therapy with regimens containing Fludarabine or in those with mutations in the p53 gene, CAMPATH-1H.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Diagnosis of relapsed or refractory CLL as defined by the NCIWG criteria, requiring treatment

• 1-3 lines of prior therapy

• Fludarabine- or Alemtuzumab-based therapy inappropriate

• WHO Performance status ≤2

• Age ≥ 18 years

• Life expectancy > 6 months

• Male and female subjects must meet the inclusion criteria for the Lenalidomide Pregnancy Prevention Risk Management Plan.

• Male and female subjects must agree to follow the Lenalidomide Pregnancy Prevention Risk Management Plan (including contraception 4 weeks before, during and 4 weeks after treatment for females of child-bearing potential).

• Signed informed consent

Exclusion Criteria:

• Previously untreated CLL

• Fit patients for whom alemtuzumab or fludarabine- based therapy would be appropriate

• Creatinine clearance < 30ml/min calculated by Cockcroft-Gault

• Bilirubin > 1.5 x upper limit of normal

• Patients with marrow suppression resulting in significant cytopenia (Neutrophils <0.5 x 109/l, Platelets <30 x 109/l).

• Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy or other investigational therapy within 4 weeks prior to study Day 1.

• Known infection with HIV, hepatitis B or hepatitis C.

• Uncontrolled glaucoma, diabetes mellitus, hypertension or symptomatic peptic ulcer disease

• Peripheral neuropathy > grade 1

• Proven or suspected transformation to aggressive B-cell malignancy (e.g. large -B-cell lymphoma, Richter's syndrome, or PLL).

• Second malignancy requiring treatment other than non metastatic skin or prostate tumours

• Any medical condition that would require long-term use (>1 month) of systemic corticosteroids at a dose greater than 5mg/day of prednisolone during study treatment.

• Active uncontrolled bacterial, viral or fungal infections Cardiac failure, myocardial infarction within 6 months prior to study day 1, or evidence of ischaemia on ECG within 30 days prior to study day 1.

• Epileptic disorders requiring anticonvulsant therapy

• Major surgery, other than diagnostic surgery within 4 weeks prior to Study Day 1.

• Pregnant or currently breastfeeding.

• Patients who for other reasons are not expected to complete the study

• Subjects with a known allergy to allopurinol