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

Completed · Phase 1

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

In brief

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.

Key facts

Study ID

NCT00419250

Run by

Celgene

People needed

52

Starts

2006-12-01

Expected to finish

2010-06-01

Last updated by the study team

2019-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Arizona Cancer Center — Tucson, Arizona, United States
• Alta Bates Summit Comprehensive Cancer Center — Berkeley, California, United States
• Desert Hematology Oncology Medical Group, Inc. — Rancho Mirage, California, United States
• Baptist Cancer Institute — Jacksonville, Florida, United States
• Cancer & Blood Disease Center — Lecanto, Florida, United States
• Northwest Georgia Oncology Centers, PC., Wellstar Health System — Marietta, Georgia, United States
• Mountain States Tumor Institute — Boise, Idaho, United States
• Robert H. Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Indiana University Medical center — Indianapolis, Indiana, United States
• LSU Health Sciences Center, Feist-Weiller Cancer Center — Shreveport, Louisiana, United States
• Karmanos Cancer Institute/Wayne State University School of Medicine — Detroit, Michigan, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Weill Medical College of Cornell University, Division of Hematology & Oncology — New York, New York, United States
• SUNY Upstate Medical Center — Syracuse, New York, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Abington Hematology Oncology Assoc., Inc. — Willow Grove, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• Cross Cancer Institute — Edmonton, Alberta, Canada
• Cancer Care Manitoba — Winnipeg, Manitoba, Canada
• Juravinski Cancer Centre — Hamilton, Ontario, Canada
• London Helath Science Centre — London, Ontario, Canada
• Saskatoon Cancer Centre — Saskatoon, Saskatchewan, Canada

Full record on ClinicalTrials.gov

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