A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Lymphocytic Leukemia, Leukemia, B-Cell, Chronic

Intervention / Treatment
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* Drug: lenalidomide
* Drug: lenalidomide
* Drug: lenalidomide
* Drug: lenalidomide
* Drug: lenalidomide


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dose-escalation to 5 mg lenalidomide (len)<br>escalate up to 5 mg once daily / 28-day cycle | Drug: lenalidomide<br> <br> * Other names: Revlimid, CC-5013;|
| Experimental: dose-escalation to 10 mg lenalidomide (len)<br>escalate up to 10 mg once daily / 28-day cycle | Drug: lenalidomide<br> <br> * Other names: Revlimid, CC-5013;|
| Experimental: dose-escalation to 15 mg lenalidomide (len)<br>escalate up to 15 mg once daily / 28-day cycle | Drug: lenalidomide<br> <br> * Other names: Revlimid, CC-5013;|
| Experimental: dose-escalation to 20 mg lenalidomide (len)<br>escalate up to 20 mg once daily / 28-day cycle | Drug: lenalidomide<br> <br> * Other names: Revlimid, CC-5013;|
| Experimental: dose-escalation to 25 mg lenalidomide (len)<br>escalate up to 25 mg once daily / 28-day cycle | Drug: lenalidomide<br> <br> * Other names: Revlimid, CC-5013;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | February 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response |  | February 2010 | 
| Duration of response |  | February 2010 | 
| Time to response |  | February 2010 | 
| Progression free survival |  | February 2010 | 
| Overall survival |  | February 2010 | 
| Absolute lymphocyte count |  | February 2010 | 
| Evaluation of minimal residual disease (MRD) by flow cytometry |  | February 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapsed, refractory, fludarabine, Revlimid, lenalidomide, CLL, B-cell CLL, CC-5013, Chronic Lymphocytic Leukemia