Clinical trial · Interventional
A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Lenalidomide (Revlimid ®) in Combination With Dexamethasone in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
NCT00474188CI-TRIAL-00002595terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business decision
Summary
Brief summary (as posted)
To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.
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 |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CC-5013 (lenalidomide) | Drug | — | UNRESOLVED |
| dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- interventionNames
- Drug: CC-5013 (lenalidomide)
- Drug: dexamethasone
Primary outcomes (1)
- measure
- Tumor Response Rate
- timeFrame
- One Year
- description
- Number of participants demonstrating complete or partial tumor response (Cheson B, Horning S, Coiffier B, Shipp M, Fisher R, Connors J, et al, Report of an international workshop to standardize response criteria for non-Hodgkins' lymphoma. J Clin Oncol.1999;17:1244-53). Study terminated prematurely. Analysis not conducted.
Secondary outcomes (4)
- measure
- Tumor Control Rate
- timeFrame
- One Year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-proven diffuse large B-cell non-Hodgkin's lymphoma * Relapsed or refractory to previous therapy for non-Hodgkin's lymphoma * Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter * ECOG performance score of 0,1 or 2 * Willing to follow the pregnancy precautions Exclusion Criteria: * Any of the following laboratory abnormalities. * Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5 x 109/L). * Platelet count \< 60,000/mm3 (60 x 109/L). * Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN). * Serum total bilirubin \> 2.0 mg/dL (34 µmol/L). * Subjects who are candidates for and willing to undergo an autologous stem cell transplant. * History of active CNS lymphoma within the previous 3 months * Subjects not willing or unable to take DVT prophylaxis * History of other malignancies within the past year * Positive HIV or active Hepatitis B or C
References
Publications (0)
Data not yet available
No reference posted for this study.