A study for adults with chronic lymphocytic leukaemia to investigate whether a new combination of drugs helps to ensure a better response than other treatments, and also to see whether or not this combination has more side effects than other treatments.

Phase 1

• Conditions: Chronic lymphocytic leukaemia; MedDRA version: 18.0 Level: PT Classification code 10008958 Term: Chronic lymphocytic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-024520-15-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-04
• Study Completion: 2016-02-01
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

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).
11. Second malignancy requiring treatment other than non metastatic skin tumours
12. 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.
13. Active uncontrolled bacterial, viral or fungal infections
14. Patients with uncontrolled cardiac failure or unstable angina
15. Epileptic disorders requiring anticonvulsant therapy
16. Major surgery, other than diagnostic surgery within 4 weeks prior to Study Day 1.
17. Pregnant or currently breastfeeding.
18. Patients who for other reasons are not expected to complete the study
19. Subjects with a known allergy to allopurinol will be excluded from the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified