A Phase II Trial to Evaluate the Safety and Activity of Single-agent Lenalidomide Given as Maintenance Therapy After Response to Second-line Therapy in Patients With Relapsed DLBCL, Not Eligible for High-dose Chemotherapy and ASCT
Patients older than 65 years or younger but not eligible to high-dose chemotherapy and
autologous stem cell transplantation with biopsy-proven diffuse large B-cell lymphoma
relapsed to previous combination chemotherapy regimen ± rituximab, who achieved at least a
partial response to second-line chemotherapy (ICE or DHAP/DHAOx or MINE regimen) + rituximab
will receive single-agent lenalidomide 25 mg once daily for 21 days out of 28, as
maintenance treatment until progression of disease. Dose reductions of study drug will be
made in case of adverse events when reported as correlated and when clinically appropriate.
One-year progression free survival will be the primary endpoint and overall survival,
response rate and toxicity will be the secondary endpoints. With the null hypothesis (P0) of
1-year PFS of 30%, this study will consider a satisfactory efficacy of lenalidomide worth of
further investigation a P1 corresponding to a 1-yr PFS of 50% (that is an absolute increase
of 20% in terms of 1-yr progression-free survival). Considering a standard type I error (α)
of 0,05 and a power of 80% (Type 2 error of 20%) 47 patients will be necessary for the
trial.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1-year progression-free survival
1-year
Yes
Andrés J. Ferreri, MD
Study Chair
San Raffaele Scientific Institute
Italy: Ministry of Health
2008-003729-18
NCT00799513
October 2009
November 2013
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