A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia, Leukemia, B-Cell, Chronic
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring relapsed, refractory, fludarabine, Revlimid, lenalidomide, CLL, B-cell CLL, CC-5013, Chronic Lymphocytic Leukemia
Eligibility Criteria
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)
Sites / Locations
- Arizona Cancer Center
- Alta Bates Summit Comprehensive Cancer Center
- Desert Hematology Oncology Medical Group, Inc.
- Baptist Cancer Institute
- Cancer & Blood Disease Center
- Northwest Georgia Oncology Centers, PC., Wellstar Health System
- Mountain States Tumor Institute
- Robert H. Lurie Comprehensive Cancer Center
- University of Chicago Medical Center
- Indiana University Medical center
- LSU Health Sciences Center, Feist-Weiller Cancer Center
- Karmanos Cancer Institute/Wayne State University School of Medicine
- Roswell Park Cancer Institute
- Weill Medical College of Cornell University, Division of Hematology & Oncology
- SUNY Upstate Medical Center
- Wake Forest University School of Medicine
- The Cleveland Clinic Foundation
- Abington Hematology Oncology Assoc., Inc.
- University of Texas MD Anderson Cancer Center
- Swedish Cancer Institute
- Cross Cancer Institute
- Cancer Care Manitoba
- Juravinski Cancer Centre
- London Helath Science Centre
- Saskatoon Cancer Centre
- Charité, Campus Benjamin Franklin, Medizinische Klinik III
- Uniklinik Köln, Klinik I für Innere Medizin, Klinisches Studienzentrum Hämatologie
- University of Schleswig Holstein, Director Medizinische Klinik II
- University of Ulm, Abteilung Innere Medizin III, Robert-Koch-Strasse 8
- Clinica Ematologica- A.O.U. San Martino, Clinica Ematologica Dipartimento di Medicina Interna
- Hospital Clinic Provincial de Barcelona, Servicio de Hematología, Institute of Haematology and Oncology
- Karolinska Universitetssjukhuset, Hematologiskt Centrum, Karolinska Universitetssjukhuset,
- St James's Institute of Oncology, Dept. of Haematology, Level 3, Bexley Wing, Beckett Street
- Bart's and the London NHS Trust, St. Bartholomew's Hospital, 7th Floor Gloucester House, Cancer Services
- Christie Hospital NHS Foundation Trust, Haematology and Transplant Unit,
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
dose-escalation to 5 mg lenalidomide (len)
dose-escalation to 10 mg lenalidomide (len)
dose-escalation to 15 mg lenalidomide (len)
dose-escalation to 20 mg lenalidomide (len)
dose-escalation to 25 mg lenalidomide (len)
escalate up to 5 mg once daily / 28-day cycle
escalate up to 10 mg once daily / 28-day cycle
escalate up to 15 mg once daily / 28-day cycle
escalate up to 20 mg once daily / 28-day cycle
escalate up to 25 mg once daily / 28-day cycle