Status:
COMPLETED
Pilot Study to Establish Safety & Efficacy of a Combination of Dexamethasone and Lenalidomide in Patients With Relapsed or Refractory Chronic Lymphocytic Leukaemia (CLL)
Lead Sponsor:
University College, London
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ar...
Detailed Description
In this study we plan to assess the safety and tolerability of the combination of dexamethasone, and lenalidomide (D+L) in patients with relapsed or refractory CLL, a subgroup with limited treatment o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01459211
Start Date
May 1 2012
End Date
February 1 2016
Last Update
November 8 2016
Active Locations (2)
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1
Royal Liverpool University Hospital
Liverpool, United Kingdom
2
University College London
London, United Kingdom, W1T 4TJ