A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic LeukemiaLeukemia, B-Cell, Chronic
- Interventions
- Registration Number
- NCT00419250
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dose-escalation to 5 mg lenalidomide (len) lenalidomide escalate up to 5 mg once daily / 28-day cycle dose-escalation to 20 mg lenalidomide (len) lenalidomide escalate up to 20 mg once daily / 28-day cycle dose-escalation to 10 mg lenalidomide (len) lenalidomide escalate up to 10 mg once daily / 28-day cycle dose-escalation to 15 mg lenalidomide (len) lenalidomide escalate up to 15 mg once daily / 28-day cycle dose-escalation to 25 mg lenalidomide (len) lenalidomide escalate up to 25 mg once daily / 28-day cycle
- Primary Outcome Measures
Name Time Method Safety February 2010
- Secondary Outcome Measures
Name Time Method Absolute lymphocyte count February 2010 Overall survival February 2010 Response February 2010 Duration of response February 2010 Time to response February 2010 Progression free survival February 2010 Evaluation of minimal residual disease (MRD) by flow cytometry February 2010
Trial Locations
- Locations (35)
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Indiana University Medical center
🇺🇸Indianapolis, Indiana, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Alta Bates Summit Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Abington Hematology Oncology Assoc., Inc.
🇺🇸Willow Grove, Pennsylvania, United States
Desert Hematology Oncology Medical Group, Inc.
🇺🇸Rancho Mirage, California, United States
Cancer Care Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Northwest Georgia Oncology Centers, PC., Wellstar Health System
🇺🇸Marietta, Georgia, United States
University of Ulm, Abteilung Innere Medizin III, Robert-Koch-Strasse 8
🇩🇪Ulm, Germany
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
London Helath Science Centre
🇨🇦London, Ontario, Canada
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
LSU Health Sciences Center, Feist-Weiller Cancer Center
🇺🇸Shreveport, Louisiana, United States
Robert H. Lurie Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
Clinica Ematologica- A.O.U. San Martino, Clinica Ematologica Dipartimento di Medicina Interna
🇮🇹Genova, Italy
Uniklinik Köln, Klinik I für Innere Medizin, Klinisches Studienzentrum Hämatologie
🇩🇪Bettenhaus Ebene 04, Raum 001/048, Kerpener Str. 62, Koln, Germany
University of Schleswig Holstein, Director Medizinische Klinik II
🇩🇪Campus Kiel, Chemnitzstrasse 33, Kiel, Germany
Cancer & Blood Disease Center
🇺🇸Lecanto, Florida, United States
Bart's and the London NHS Trust, St. Bartholomew's Hospital, 7th Floor Gloucester House, Cancer Services
🇬🇧London, United Kingdom
Christie Hospital NHS Foundation Trust, Haematology and Transplant Unit,
🇬🇧Manchester, United Kingdom
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Hospital Clinic Provincial de Barcelona, Servicio de HematologÃa, Institute of Haematology and Oncology
🇪🇸Villaroel, 170, Barcelona, Spain
Baptist Cancer Institute
🇺🇸Jacksonville, Florida, United States
Weill Medical College of Cornell University, Division of Hematology & Oncology
🇺🇸New York, New York, United States
Mountain States Tumor Institute
🇺🇸Boise, Idaho, United States
SUNY Upstate Medical Center
🇺🇸Syracuse, New York, United States
Charité, Campus Benjamin Franklin, Medizinische Klinik III
🇩🇪Hindenburgdamm 30, Berlin, Germany
Karolinska Universitetssjukhuset, Hematologiskt Centrum, Karolinska Universitetssjukhuset,
🇸🇪Stockholm, Sweden
Karmanos Cancer Institute/Wayne State University School of Medicine
🇺🇸Detroit, Michigan, United States
St James's Institute of Oncology, Dept. of Haematology, Level 3, Bexley Wing, Beckett Street
🇬🇧Leeds, United Kingdom
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States