A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
NCT ID: NCT00419250
Last Updated: 2019-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2006-12-01
2010-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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dose-escalation to 5 mg lenalidomide (len)
escalate up to 5 mg once daily / 28-day cycle
lenalidomide
dose-escalation to 10 mg lenalidomide (len)
escalate up to 10 mg once daily / 28-day cycle
lenalidomide
dose-escalation to 15 mg lenalidomide (len)
escalate up to 15 mg once daily / 28-day cycle
lenalidomide
dose-escalation to 20 mg lenalidomide (len)
escalate up to 20 mg once daily / 28-day cycle
lenalidomide
dose-escalation to 25 mg lenalidomide (len)
escalate up to 25 mg once daily / 28-day cycle
lenalidomide
Interventions
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lenalidomide
lenalidomide
lenalidomide
lenalidomide
lenalidomide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG \< or = 2
* Willing to agree to follow the pregnancy precautions.
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Elayne Lombardy, MD
Role: STUDY_DIRECTOR
Celgene Corporation
Asher Chanan-Khan, MD
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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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
Uniklinik Köln, Klinik I für Innere Medizin, Klinisches Studienzentrum Hämatologie
Bettenhaus Ebene 04, Raum 001/048, Kerpener Str. 62, Koln, Germany
Charité, Campus Benjamin Franklin, Medizinische Klinik III
Hindenburgdamm 30, State of Berlin, Germany
University of Schleswig Holstein, Director Medizinische Klinik II
Campus Kiel, Chemnitzstrasse 33, Kiel, , Germany
University of Ulm, Abteilung Innere Medizin III, Robert-Koch-Strasse 8
Ulm, , Germany
Clinica Ematologica- A.O.U. San Martino, Clinica Ematologica Dipartimento di Medicina Interna
Genova, , Italy
Hospital Clinic Provincial de Barcelona, Servicio de Hematología, Institute of Haematology and Oncology
Villaroel, 170, Barcelona, , Spain
Karolinska Universitetssjukhuset, Hematologiskt Centrum, Karolinska Universitetssjukhuset,
Stockholm, , Sweden
St James's Institute of Oncology, Dept. of Haematology, Level 3, Bexley Wing, Beckett Street
Leeds, , United Kingdom
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
Countries
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References
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Wendtner CM, Hillmen P, Mahadevan D, Buhler A, Uharek L, Coutre S, Frankfurt O, Bloor A, Bosch F, Furman RR, Kimby E, Gribben JG, Gobbi M, Dreisbach L, Hurd DD, Sekeres MA, Ferrajoli A, Shah S, Zhang J, Moutouh-de Parseval L, Hallek M, Heerema NA, Stilgenbauer S, Chanan-Khan AA. Final results of a multicenter phase 1 study of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia. Leuk Lymphoma. 2012 Mar;53(3):417-23. doi: 10.3109/10428194.2011.618232. Epub 2011 Nov 15.
Other Identifiers
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CC-5013-CLL-001
Identifier Type: -
Identifier Source: org_study_id
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