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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00419250

Enrollment

Registered

2007-01-08

Start date

2006-12-01

Completion date

2010-06-01

Last updated

2019-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia, Leukemia, B-Cell, Chronic

Keywords

relapsed, refractory, fludarabine, Revlimid, lenalidomide, CLL, B-cell CLL, CC-5013, Chronic Lymphocytic Leukemia

Brief summary

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.

Interventions

DRUGlenalidomide

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Safety	February 2010

Secondary

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

Countries

Canada, Germany, Italy, Spain, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026