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

This study has been completed.
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )
ClinicalTrials.gov Identifier:
First received: January 5, 2007
Last updated: August 26, 2013
Last verified: August 2013
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.

Condition Intervention Phase
Chronic Lymphocytic Leukemia
Leukemia, B-Cell, Chronic
Drug: lenalidomide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Celgene:

Primary Outcome Measures:
  • Safety [ Time Frame: February 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response [ Time Frame: February 2010 ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: February 2010 ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: February 2010 ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: February 2010 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: February 2010 ] [ Designated as safety issue: No ]
  • Absolute lymphocyte count [ Time Frame: February 2010 ] [ Designated as safety issue: No ]
  • Evaluation of minimal residual disease (MRD) by flow cytometry [ Time Frame: February 2010 ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: December 2006
Study Completion Date: June 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dose-escalation to 5 mg lenalidomide (len)
escalate up to 5 mg once daily / 28-day cycle
Drug: lenalidomide
Other Name: Revlimid, CC-5013
Experimental: dose-escalation to 10 mg lenalidomide (len)
escalate up to 10 mg once daily / 28-day cycle
Drug: lenalidomide
Other Name: Revlimid, CC-5013
Experimental: dose-escalation to 15 mg lenalidomide (len)
escalate up to 15 mg once daily / 28-day cycle
Drug: lenalidomide
Other Name: Revlimid, CC-5013
Experimental: dose-escalation to 20 mg lenalidomide (len)
escalate up to 20 mg once daily / 28-day cycle
Drug: lenalidomide
Other Name: Revlimid, CC-5013
Experimental: dose-escalation to 25 mg lenalidomide (len)
escalate up to 25 mg once daily / 28-day cycle
Drug: lenalidomide
Other Name: Revlimid, CC-5013


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419250

  Hide Study Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, United States, 92270
United States, Florida
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Cancer & Blood Disease Center
Lecanto, Florida, United States, 34461
United States, Georgia
Northwest Georgia Oncology Centers, PC., Wellstar Health System
Marietta, Georgia, United States, 30060
United States, Idaho
Mountain States Tumor Institute
Boise, Idaho, United States, 83712
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611
University of Chicago Medical Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Medical center
Indianapolis, Indiana, United States, 46202-5149
United States, Louisiana
LSU Health Sciences Center, Feist-Weiller Cancer Center
Shreveport, Louisiana, United States, 71130
United States, Michigan
Karmanos Cancer Institute/Wayne State University School of Medicine
Detroit, Michigan, United States, 48201
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Weill Medical College of Cornell University, Division of Hematology & Oncology
New York, New York, United States, 10021
SUNY Upstate Medical Center
Syracuse, New York, United States, 13210
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Abington Hematology Oncology Assoc., Inc.
Willow Grove, Pennsylvania, United States, 19090
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Helath Science Centre
London, Ontario, Canada, N6C 6B5
Canada, Saskatchewan
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Charité, Campus Benjamin Franklin, Medizinische Klinik III
Hindenburgdamm 30, Berlin, Germany, 12203
Uniklinik Köln, Klinik I für Innere Medizin, Klinisches Studienzentrum Hämatologie
Bettenhaus Ebene 04, Raum 001/048, Kerpener Str. 62, Koln, Germany, 50924
University of Schleswig Holstein, Director Medizinische Klinik II
Campus Kiel, Chemnitzstrasse 33, Kiel, Germany, 24116
University of Ulm, Abteilung Innere Medizin III, Robert-Koch-Strasse 8
Ulm, Germany, 89081
Clinica Ematologica- A.O.U. San Martino, Clinica Ematologica Dipartimento di Medicina Interna
Genova, Italy, 16132
Hospital Clinic Provincial de Barcelona, Servicio de Hematología, Institute of Haematology and Oncology
Villaroel, 170, Barcelona, Spain, 8036
Karolinska Universitetssjukhuset, Hematologiskt Centrum, Karolinska Universitetssjukhuset,
Stockholm, Sweden, 141 86
United Kingdom
St James's Institute of Oncology, Dept. of Haematology, Level 3, Bexley Wing, Beckett Street
Leeds, United Kingdom, LS9 7TF
Bart's and the London NHS Trust, St. Bartholomew's Hospital, 7th Floor Gloucester House, Cancer Services
London, United Kingdom, EC1A 7BE
Christie Hospital NHS Foundation Trust, Haematology and Transplant Unit,
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Celgene Corporation
Study Director: Elayne Lombardy, MD Celgene Corporation
Principal Investigator: Asher Chanan-Khan, MD Roswell Park Cancer Institute
  More Information

Responsible Party: Celgene ( Celgene Corporation )
ClinicalTrials.gov Identifier: NCT00419250     History of Changes
Other Study ID Numbers: CC-5013-CLL-001 
Study First Received: January 5, 2007
Last Updated: August 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene:
B-cell CLL
Chronic Lymphocytic Leukemia

Additional relevant MeSH terms:
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2016