drugset / Trial / NCT00968331

Study of Lenalidomide(Revlimid) Plus Rituximab (Revlirit Regimen) in Elderly Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

NCT00968331 ↗

Phase 2 Terminated 25 enrolled University of Bologna
NaSingle-groupOpen-labelTreatment

Summary

Oral Lenalidomide is initiated on day 1 of cycle 1 at the dose of 20 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles. Rituximab is administered on day 1 and day 21 of each cycle at the dose of 375 mg/m2 for a total of 4 cycles. After this induction phase, the CR, PR and SD will continue Lenalidomide with the same schedule for other 8 months.

Timeline

Start
2009-03
Primary completion
2009-12
Completion
2011-12

Outcome

Outcome not reported

Stopped: “The EC withdrawn the approval becuase of possible conflicts of interests between our Institute and Supporter (Celgene)”

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified 20 mg Oral
Subject Rituximab Monoclonal antibody 375 mg/m2 —