Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With Diffuse Large B cell Lymphoma (DLBCL) and Treated With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
Double blind randomized phase III study of Lenalidomide (Revlimid Registered Trademark) maintenance versus Placebo in responding elderly patients with diffuse large B cell lymphoma (DLBCL) and treated with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in first line
Australasian Leukaemia and Lymphoma Group
80 participants
Mar 8, 2011
Interventional
Conditions
Summary
In patients between 60-80 years with diffuse large B cell lymphoma (DLBCL), the current standard treatment is R-CHOP chemotherapy (consisting of the drugs Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). However the probability of being alive and free of lymphoma 5 years after diagnosis is only 54%. Lenalidomide is an immune system modulating drug that has anti-lymphoma properties demonstrated in smaller studies of patients with relapsed/refractory DLBCL. Given the high risk of relapsed DLBCL in this older patient population this study is aimed at determining whether Lenalidomide maintenance taken orally for 21 days every 4 weeks can safely reduce the risk of progression/relapse of DLBCL. Who is it for? This study is open to patients aged between 60 and 80 years and currently underoing R-CHOP combination therapy for diffuse large B-cell lymphoma. Trial details Participants will be randomised into one of two arms, (1) 25mg daily lenalidomide for 21 days of a 28 day cycle of maintenenace therapy for up to 26 cycles, or (2) a placebo instead of the active drug over the same period. The aim of the study is to reduce the risk of progression/relapse of DLBCL
Eligibility
Plain Language Summary
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Interventions
25mg daily lenalidomide for 21 days of a 28 day cycle of maintenance therapy for up to 26 cycles. Lenalidomide is an oral tablet.
Locations(3)
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ACTRN12611000085976