This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival (PFS) in patients treated with R-CHOP responding to induction therapy For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs 73.6%), is considered clinically relevant.
Patients should have received at least 6 and up to 8 cycles of the R-CHOP 14 or R-CHOP 21 regimen or 6 R-CHOP-14 or -21 completed by 2 Rituximab alone in accordance to local preferences. Patients can be registered to participate in the study at two time points: * At time of initial diagnosis and study enrolment (signature of informed consent) before the first cycle of treatment with R-CHOP. * At randomization (signature of informed consent) after treatment in first line with R-CHOP and have reached at least PR or CR. Evaluation of the response to R-CHOP must be in accordance with Revised Response Criteria for Malignant Lymphoma(2007). Stratification: Before randomization, the patients will be stratified according to the country and the response to R-CHOP (PR vs CR). Randomization: Patients in CR/PR after R-CHOP will be randomized to maintenance therapy with lenalidomide or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
650
Daily for 3 weeks every 4 weeks for 24 months
Daily for 3 weeks every 4 weeks for 24 months
Bendigo Hospital
Bendigo, Australia
Concord Repatriation General Hospital
Concord, Australia
Flinders Medical Centre - Repatriation General Hospital
Daw Park, Australia
St Vincent's Hospital, Melbourne
Fitzroy, Australia
Frankston Hospital Monash Medical Centre
Frankston, Australia
Fremantle Hospital
Progression-Free-Survival (PFS)
PFS will be measured from the date of randomization to the date of first documented disease progression or death. Progression data will be assigned to the earliest time when any progression is observed without prior missing assessments during the study up to the end of the follow up phase.
Time frame: Final PFS analysis will be realized when the number of events (160) has been reached or at the latest when the last patient into the study will finish follow up. The approximate schedule will be 75 months after the first patient randomized.
Overall survival (OS)
From the date of randomization to the date of death from any cause Interim analysis of OS will be performed at the time of the PFS final analysis; it is projected to have 97 deaths at this time. Final analysis of OS at the end of the study, defined by the last visit of follow-up for the last patient randomized, 5 years after its randomization
Time frame: 5 years
Event-Free Survival (EFS)
From the date of randomization to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause Interim analysis of EFS will be performed at the time of the PFS final analysis. Final analysis of OS at the end of the study, defined by the last visit of follow-up for the last patient randomized, 5 years after its randomization
Time frame: 5 years
Response rate at the end of maintenance treatment
Time frame: 24 months
Percentage of patients who convert from PR (partial response) to CR (complete response)
Time frame: 24 months
Safety of lenalidomide in maintenance
Toxicities occured during maintenance phase will be measured and reported from grade 2 for infection and neurological toxicities and from grade 3 for other toxicities according to CTCAE v3
Time frame: 5 years
PFS2
From randomization to objective tumor progression on next-line treatment or death from any cause
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fremantle, Australia
Canberra Hospital
Garran, Australia
Austin Hospital
Heidelberg, Australia
Royal Hobart Hospital
Hobart, Australia
Mater Misericordiae Hospital - Calvary Mater NewCastle
Hunter, Australia
...and 147 more locations