Double Blind Randomized Phase III Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP in First Line
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
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.
Ages Eligible for Study: Between 60 and 80 years old
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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.
Final PFS analysis will be realized when the number of events (282) 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.
Bertrand COIFFIER, Prof
Lymphoma Study Association
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)