Phase 2
Completed N=217
A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma
Source: ClinicalTrials.gov NCT00413036 ↗Enrolled (actual)
217
Serious AEs
47.0%
Results posted
Apr 2013
Primary outcomePrimary: Participants Categorized by Best Response as Determined by Central Review — 7; 21; 40; 71 Participants
Summary
Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Categorized by Best Response as Determined by Central Review |
7; 21; 40; 71; 78 | — |
| SECONDARY Duration of Response as Determined by Central Review |
18.4 | — |
| SECONDARY Time to Progression as Determined by Central Review |
4.5 | — |
| SECONDARY Progression-free Survival as Determined by Central Review |
4.5 | — |
| SECONDARY Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review |
— | — |
Eligibility Criteria
Key Inclusion criteria
- Biopsy proven aggressive non-hodgkin's lymphoma
- Follicular center lymphoma Grade 3.
- Diffuse large B-cell lymphoma.
- Mantle cell lymphoma.
- Transformed lymphoma.
- Relapsed or refractory to previous therapy for lymphoma
- At least one prior combination chemotherapy regime
- Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
- Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2
- Willing to follow the pregnancy precautions
Key Exclusion criteria
- Any of the following laboratory abnormalities.
- Absolute neutrophil count (ANC) 2.0 mg/dL (34 µmol/L)/conjugated bilirubin >0.8mg/dL.
- Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
- History of active Central Nervous System (CNS) lymphoma within the previous 6 months
- History of other malignancies within the past year
- Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C
Data sourced from ClinicalTrials.gov (NCT00413036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.