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

November 6, 2019 updated by: Celgene

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: February 2010
February 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
Response
Time Frame: February 2010
February 2010
Duration of response
Time Frame: February 2010
February 2010
Time to response
Time Frame: February 2010
February 2010
Progression free survival
Time Frame: February 2010
February 2010
Overall survival
Time Frame: February 2010
February 2010
Absolute lymphocyte count
Time Frame: February 2010
February 2010
Evaluation of minimal residual disease (MRD) by flow cytometry
Time Frame: February 2010
February 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2006

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

January 5, 2007

First Submitted That Met QC Criteria

January 5, 2007

First Posted (Estimate)

January 8, 2007

Study Record Updates

Last Update Posted (Actual)

November 8, 2019

Last Update Submitted That Met QC Criteria

November 6, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-5013-CLL-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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