At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 43 enrolled
Drug / intervention
Lenalidomidedrug
Likely dose
Not stated in record
Key inclusion· 5
- ✓Biopsy-proven indolent non-Hodgkin's lymphoma of specific histologies (follicular grades 1-2, marginal zone, SLL, lymphoplasmacytoid)
- ✓Relapsed or refractory to at least one prior treatment regimen (chemotherapy, immunotherapy, radiation, or radioimmunotherapy); ineligible or unwilling for autologous stem cell transplant
- ✓Measurable disease on imaging ≥2 cm in longest diameter
- ✓Age ≥18 years
Key exclusion· 8
- ✕Prior use of lenalidomide
- ✕Grade ≥3 allergic reaction or hypersensitivity to thalidomide
- ✕Grade ≥3 rash or desquamating rash with thalidomide
- ✕Active CNS disease (unless treated and asymptomatic for ≥6 months with imaging confirmation)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
In Brief
A Phase 2 clinical trial evaluating Lenalidomide for Non-Hodgkins Lymphoma. Completed, enrolled 43 participants across 15 sites in 2 countries.
Detailed Summary
Subjects who qualify will receive lenalidomide daily on days 1-21 of every 28-day cycle. Treatment will continue for up to 52 weeks or until disease progression; subjects who achieve a Complete Response (CR) will receive an additional 2 cycles of treatment prior to discontinuation. Subjects will be followed for progression free survival following discontinuation from the treatment phase
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkins Lymphoma
CountriesCanada, United States
CollaboratorsPrologue Research International
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2005
First PostedSep 2005
Primary CompletionApr 2008
TodayJul 2026
First PostedSep 16, 2005
Enrollment StartJun 1, 2005
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.8 years ago
Interventions
Lenalidomidedrug