Clinical trial · Interventional
A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma
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 Aggressive Non-Hodgkin's Lymphoma
NCT00413036CI-TRIAL-00026197completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin's | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- lenalidomide
- description
- 25 mg oral lenalidomide once daily on Days 1-21 every 28 days
- interventionNames
- Drug: lenalidomide
Primary outcomes (1)
- measure
- Participants Categorized by Best Response as Determined by Central Review
- timeFrame
- Up to 1459 days
- description
- Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article. * Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy. * Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass \>1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow. * Partial Response(PR): \>50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson. * Stable Disease(SD): Less than PR, but not progressive disease. * Progressive Disease(PD): Appearance of new lesion during/end of therapy; \>=50% increase from lowest measurement in SPD.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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) \< 1,500 cells/mm\^3 (1.5\*10\^9/L). * Platelet count \< 60,000/mm\^3 (60\*10\^9/L). * Calculated creatinine clearance of \<50mL/min * Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) or Serum glutamic pyruvic transaminase/Alanine transaminase (SGPT/ALT) 5.0 times upper limit of normal (ULN). * Serum total bilirubin \> 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
References
Publications (2)
- RESULTZinzani PL, Vose JM, Czuczman MS, Reeder CB, Haioun C, Polikoff J, Tilly H, Zhang L, Prandi K, Li J, Witzig TE. Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study. Ann Oncol. 2013 Nov;24(11):2892-7. doi: 10.1093/annonc/mdt366. Epub 2013 Sep 12. PMID 24030098
- RESULTWitzig TE, Vose JM, Zinzani PL, Reeder CB, Buckstein R, Polikoff JA, Bouabdallah R, Haioun C, Tilly H, Guo P, Pietronigro D, Ervin-Haynes AL, Czuczman MS. An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. Ann Oncol. 2011 Jul;22(7):1622-1627. doi: 10.1093/annonc/mdq626. Epub 2011 Jan 12. PMID 21228334