Clinical trial · Interventional
A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
A Phase 1, Multi-center, Open-label Study of the Safety and Efficacy of a Stepwise Dose-escalation Schedule of Lenalidomide Monotherapy in Subjects With Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
NCT00419250CI-TRIAL-00041551completedPhase 1ClinicalTrials.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)
The purpose of this study is to evaluate the safety of lenalidomide and to define the maximum tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation schedule in subjects with relapsed or refractory B-cell CLL.
Conditions
Conditions (2)
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 |
| Leukemia, B-Cell, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- dose-escalation to 5 mg lenalidomide (len)
- description
- escalate up to 5 mg once daily / 28-day cycle
- interventionNames
- Drug: lenalidomide
- type
- EXPERIMENTAL
- label
- dose-escalation to 10 mg lenalidomide (len)
- description
- escalate up to 10 mg once daily / 28-day cycle
- interventionNames
- Drug: lenalidomide
- type
- EXPERIMENTAL
- label
- dose-escalation to 15 mg lenalidomide (len)
- description
- escalate up to 15 mg once daily / 28-day cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented diagnosis of B-cell CLL that has relapsed after or is refractory to at least one prior regimen. The prior regimen(s) must have included an alkylating agent and fludarabine (used in combination or separately) * ECOG \< or = 2 * Willing to agree to follow the pregnancy precautions. Exclusion Criteria: * Pregnant or nursing women * Systemic treatment for B-cell CLL within 28 days of study start * Central nervous system involvement * History of renal failure requiring dialysis * Prior treatment with lenalidomide * Alemtuzumab therapy within 56 days of initiating lenalidomide treatment * ANC \< 1000 / ul * Platelet count \< 50,000 / ul * Calculated creatinine clearance \< 60 mL/min (Cockroft-Gault method) * AST or ALT \> 3.0 x upper limit of normal * Serum total bilirubin \> 2.0 mg/dl * Neuropathy \> or = Grade 2 * Uncontrolled autoimmune hemolytic anemia or thrombocytopenia * Richter's transformation (active)
References
Publications (1)
- BACKGROUNDWendtner CM, Hillmen P, Mahadevan D, Buhler A, Uharek L, Coutre S, Frankfurt O, Bloor A, Bosch F, Furman RR, Kimby E, Gribben JG, Gobbi M, Dreisbach L, Hurd DD, Sekeres MA, Ferrajoli A, Shah S, Zhang J, Moutouh-de Parseval L, Hallek M, Heerema NA, Stilgenbauer S, Chanan-Khan AA. Final results of a multicenter phase 1 study of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia. Leuk Lymphoma. 2012 Mar;53(3):417-23. doi: 10.3109/10428194.2011.618232. Epub 2011 Nov 15. PMID 21879809