Clinical trial · Interventional
Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
Maintenance Therapy With Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
NCT01465230CI-TRIAL-00015890terminatedPhase 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): This study was unsuccessful in enrolling the target number of subjects during the funding period.
Summary
Brief summary (as posted)
This study will determine whether or not Lenalidomide improves effectiveness of treatment for chronic lymphocytic leukemia following chemotherapy with two drugs commonly used to treat the disease (bendamustine and rituximab).
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 |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Maintenance lenalidomide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- lenalidomide
- description
- Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
- interventionNames
- Drug: Maintenance lenalidomide
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- 36 months
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Previous induction treatment with bendamustine and rituximab * 18 or more years of age * chronic lymphocytic leukemia * ECOG performance status less than or equal to 2 * Absolute neutrophile count more than 1,000 * Platelet count more than 70,000 Exclusion Criteria: * Serious medical condition that would prevent treatment with lenalidomide * Evidence of tumor lysis syndrome * Any prior treatment with lenalidomide
References
Publications (0)
Data not yet available
No reference posted for this study.