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Lenalidomide and BCG for Non-muscle-invasive Bladder Cancer
NCT01373294Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2011
- Primary completion
- Jan 2015
- Countries
- 1
- Sponsor
- Moffitt Cancer Center
- Modality
- Small Molecules
- Drugs
- lenalidomide
- Conditions
- non-muscle-invasive bladder cancer (NMIBC)
01
Overview
Phase 2, open-label trial of lenalidomide in non-muscle-invasive bladder cancer (NMIBC) (2 arms), sponsored by Moffitt Cancer Center. Primary endpoint: Progression Free Survival at 1 year. Started Nov 2011; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Combination Arm
BCG + Revlimid
Control Arm
BCG only
03
Who it enrols
Patients with Ta high grade, T1 high grade or Tis transitional cell bladder cancer, s/p TURBT. Combination arm requires prior BCG treatment.
04
Endpoints
Primary
Progression Free Survival
Secondary
Treatment Emergent Adverse Events or Serious Adverse Events
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