ECOG E2408: A 3-Arm Randomized Phase II Trial of Bendamustine-Rituximab (BR) Followed by Rituximab vs Bortezomib-BR (BVR) Followed by Rituximab vs BR Followed by Lenalidomide/Rituximab in High Risk Follicular Lymphoma

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ECOG E2408: A 3-Arm Randomized Phase II Trial of Bendamustine-Rituximab (BR) Followed by Rituximab vs Bortezomib-BR (BVR) Followed by Rituximab vs BR Followed by Lenalidomide/Rituximab in High Risk Follicular Lymphoma

PRIMARY OBJECTIVES:
1.To compare the complete remission (CR) rate of BR versus BVR as induction
therapy.
2. To compare the 1-year post-induction disease-free survival (DFS) rate with rituximab plus lenalidomide to rituximab alone as continuation therapy.

Secondary Objectives
1. To determine the 3-year progression-free survival (PFS) and the 5-year overall
survival (OS) with BR, BVR, lenalidomide plus rituximab, and rituximab alone.
2. To evaluate patient-reported outcomes at baseline and during treatment to
determine differences in symptom palliation, treatment-related symptoms and overall health-related quality of life (HRQL) according to treatment arm.
3. To examine the association between baseline FLIPI information and outcome (CR,DFS, PFS, and OS).
4. To examine the association between baseline and end-of-treatment patient comorbidities assessed by the Cumulative Illness Rating Scale (CIRS) and outcome(CR, DFS, PFS, and OS).
5. To create an image and tissue bank including serial PET/CT scans, diagnostic
paraffin-embedded tissue, germline DNA, and serial blood and bone marrow
samples sufficient to support proposed and future studies of tumor and host
characteristics that may predict for clinical outcome, including treatment arm effects,and enhance existing prognostic indices.

Protocol Number011101
Principal InvestigatorKevin David
PhasePhase II
ScopeNational
Applicable Disease SitesNon-Hodgkin's Lymphoma
Therapies InvolvedChemotherapy multiple agents systemic
Drugs InvolvedBENDAMUSTINE
RITUXIMAB
LENALIDOMIDE
BORTEZOMIB
Participating InstitutionsRutgers Cancer Institute of New Jersey
Robert Wood Johnson University Hospital at Hamilton

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.