A Multicenter, Open Label, Phase II Study of Bendamustine and Rituximab followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma (Fol-BRITe)
Conditions
Follicular Lymphoma
What is the purpose of this trial?
| STUDY OBJECTIVES Primary Objective: To determine the complete response (CR) rate and overall response (OR) rate [CR + partial response (PR) rate] to a regimen of bendamustine and rituximab (B-R), followed by radioimmunotherapy (RIT) with 90-yttrium(Y) ibritumomab tiuxetan in subjects with untreated follicular lymphoma. Secondary Objectives: To characterize the safety profile of bendamustine and rituximab followed by 90-yttrium(Y) ibritumomab tiuxetan in subjects with untreated follicular lymphoma To determine the CR and OR rate after B-R To determine the CR and OR rate after 90-yttrium(Y) ibritumomab tiuxetan specifically the conversions from PR to CR To determine the progression-free survival (PFS) To determine time to next treatment (TTNT) Exploratory Objectives: To determine the molecular response after B-R as determined by qualitative polymerase chain reaction (PCR) of BCL2 from blood and bone marrow examination (required after B-R) To determine the molecular response after 90-yttrium(Y) ibritumomab tiuxetan radioimmunotherapy from blood and bone marrow examination (required after RIT) |
Participation Guidelines
- Age:
- 18 Years and older
- Gender:
- Both
Click here for detailed information about who can participate in this trial.
- Sponsor:
- Cephalon
Dartmouth-Hitchcock Medical Center
Spectrum Pharmaceuticals, Inc - Dates:
- October 2012
- Last Updated:
- Study HIC#:
- 1207010545
Clinicaltrials.gov ID: Yale2349468


