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

Sponsor
Celgene (Industry)
Overall Status
Completed
CT.gov ID
NCT00419250
Collaborator
(none)
52
35
5
42
1.5
0

Study Details

Study Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Actual Study Start Date :
Dec 1, 2006
Actual Primary Completion Date :
Feb 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: dose-escalation to 5 mg lenalidomide (len)

escalate up to 5 mg once daily / 28-day cycle

Drug: lenalidomide
Other Names:
  • Revlimid, CC-5013
  • Experimental: dose-escalation to 10 mg lenalidomide (len)

    escalate up to 10 mg once daily / 28-day cycle

    Drug: lenalidomide
    Other Names:
  • Revlimid, CC-5013
  • Experimental: dose-escalation to 15 mg lenalidomide (len)

    escalate up to 15 mg once daily / 28-day cycle

    Drug: lenalidomide
    Other Names:
  • Revlimid, CC-5013
  • Experimental: dose-escalation to 20 mg lenalidomide (len)

    escalate up to 20 mg once daily / 28-day cycle

    Drug: lenalidomide
    Other Names:
  • Revlimid, CC-5013
  • Experimental: dose-escalation to 25 mg lenalidomide (len)

    escalate up to 25 mg once daily / 28-day cycle

    Drug: lenalidomide
    Other Names:
  • Revlimid, CC-5013
  • Outcome Measures

    Primary Outcome Measures

    1. Safety [February 2010]

    Secondary Outcome Measures

    1. Response [February 2010]

    2. Duration of response [February 2010]

    3. Time to response [February 2010]

    4. Progression free survival [February 2010]

    5. Overall survival [February 2010]

    6. Absolute lymphocyte count [February 2010]

    7. Evaluation of minimal residual disease (MRD) by flow cytometry [February 2010]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

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

    Sponsors and Collaborators

    • Celgene

    Investigators

    • Study Director: Elayne Lombardy, MD, Celgene Corporation
    • Principal Investigator: Asher Chanan-Khan, MD, Roswell Park Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT00419250
    Other Study ID Numbers:
    • CC-5013-CLL-001
    First Posted:
    Jan 8, 2007
    Last Update Posted:
    Nov 8, 2019
    Last Verified:
    Nov 1, 2019

    Study Results

    No Results Posted as of Nov 8, 2019