A Phase 2 interventional study of Lenalidomide & Dexamethasone in Chronic Lymphocytic Leukemia, sponsored by University College, London. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-08.
Sponsored by University College, London · Phase 2, Interventional, and Treatment
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.
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 options. Lenalidomide offers an alternative way of treating CLL. In a Phase 1 safety and pharmacokinetics study (study 1398/180) in healthy male volunteers, it was demonstrated that lenalidomide administered at a dose of 100 mg twice a day for 6 days had an acceptable safety profile with grade 1-2 rash and pruritus being the primary adverse events associated with the administration of the compound. In myeloma and MDS, lenalidomide has been studied mostly at two doses: 25 mg/day and 10 mg/day. In CLL significant toxicity was observed with these two dose levels, including tumour lysis syndrome and tumour flare.47,48 We therefore plan to start therapy with lenalidomide at a relatively low dose of 5mg/day, days 1-28, with cycle 1 and escalate to the maximum dose of 10mg/day with cycles 2-12. We have elected to administer lenalidomide continuously as opposed to pulsing over 14-21 days of each cycle to reduce the risk of tumour flare reaction (TFR), when this agent is reintroduced with each cycle. Finally, lenalidomide will be administered in combination with Dexamethasone, at a dose of 20mg/day for 4 days in each 28 day cycle as this allows convenient oral administration. We and others have demonstrated that Dexamethasone level is effective in CLL patients who are refractory or have relapsed following primary Fludarabine therapy. The combination of D+L will likely reduce toxicity, especially TFR, whilst improving overall efficacy without promoting the emergence of chemoresistant clones in which tumour suppressor genes have been inactivated.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 12 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
Lenalidomide, 5mg daily, increased to 10mg after 1st cycle. Dexamethasone, 20mg days 1-4 each cycle
Drug: Lenalidomide & Dexamethasone
Subjects with relapsed or refractory CLL will receive twelve 28-day cycles of treatment. Each cycle will consist of: 1. Oral Dexamethasone (20mg daily, days 1-4), 2. Oral Lenalidomide on days 1-28 of each cycle, starting at 5mg per day in cycle 1 in patients with creatinine clearance ≥ 60ml/min calculated by Cockcroft-Gault. The dose will be increased to 10mg per day with cycles 2-12 unless there is evidence of disease progression or unacceptable drug toxicity
Also known as: Revlimid
Proportion of patients who achieve objective response (CR + PR) according to the updated 1996 NCIWG criteria measured at 4 weeks after the completion of chemotherapy
Time frame: 4 weeks after the completion of chemotherapy
Duration of response
Response will be assessed 4 weeks after completion or discontinuation of treatment. Response and disease status will be assessed at monthly follow up visits until 6 months post completion or discontinuation of treatment. After this patients will be assessed annually until death and the date of first relapse or progression will be recorded for every patient, therefore giving a duration of response in months.
Time frame: Time from initial response to first relapse/progression or death
Time to next treatment
Patients will be assessed after completion or discontinuation of treatment monthly until 6 months, and then assessed annually. At these assessments the patients status will be assessed and any further treatment for the disease will be recorded and the date of this treatment. Therefore the time from end of chemotherapy to next treatment will be recorded for each patient, in months.
Time frame: Time from end of chemotherapy to next treatment
Plan to share: Undecided
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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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University College, London