The research project is trying to find out if we can improve the results of best available chemotherapy for Chronic Lymphocytic Leukaemia (CLL) by the addition of a new drug called lenalidomide.
An Australasian and French Phase III, Multicentre, Randomised Trial Comparing Lenalidomide Consolidation versus No Consolidation in Patients With Chronic Lymphocytic Leukaemia and Residual Disease Following Induction Chemotherapy
Australasian Leukaemia and Lymphoma Group (ALLG)
192 participants
May 27, 2011
Interventional
Conditions
Summary
to assess the effect of lenalidomide consolidation (vs observation with no further therapy) in previously untreated CLL patients with measurable disease after at least 4 cycles of FCR therapy.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
After initial chemotherapy (the standard routine chemotherapy given to patients with CLL) patients will be randomised to either follow-up or to new medication Lenalidomide. Patients randomised to followup will visit their clinician regularly and have blood tests for the same amount of time as those randomised to Lenalidomide. Those randomised to Lenalidomide will commence at 5mg (2.5 mg for those with renal impairment) and, if tolerated, escalate to a maximum of 10mg (5mg in renally impaired) in 2.5mg increments every 2 cycles. At day 28 patient will undergo blood tests to ensure safe to continue with treatment. A new cycle will commence at the appropriate dose. This will occur for 24 months (2years).
Locations(1)
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ACTRN12610000060044