Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00963105
First received: August 20, 2009
Last updated: July 7, 2016
Last verified: July 2016
  Purpose
The purpose of this study is to determine the safety and effectiveness of different dose regimen of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia.

Condition Intervention Phase
Relapsed or Refractory Chronic Lymphocytic Leukemia
Drug: lenalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Randomized, Double-Blinded, Parallel Group Study of the Safety and Efficacy of Different Lenalidomide Dose Regimens in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Safety [type, frequency, and severity of adverse events (AEs) and relationship of AEs to lenalidomide] [ Time Frame: up to 55 months ] [ Designated as safety issue: Yes ]
    Number, type, frequency, and severity of adverse events (AEs) and treatment emergent adverse events associated to lenalidomide


Secondary Outcome Measures:
  • Response rate (RR); International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines for diagnosis and treatment of CLL [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
    Best response during the treatment period will be assessed by the IwCLL guidelines for diagnosis and treatment of CLL (Hailek, 2008)

  • Duration of response (DOR) [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
    The duration of response is defined as the time from first visit or at least partial response was documented until PD.

  • Time to response (TTR) [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
    Time to first response is calculated as the time from randomization to the first document date of at least partial response

  • Time to progression (TTP) [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
    TTP is defined as the time from randomization to the first documented progression.

  • Event-Free survival (EFS) [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
    EFS is the interval between the start of treatment to the first sign of disease progression, or treatment for relapse or death (whichever comes first)

  • Progression Free survival (PFS) [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
    PFS is defined as the time randomization to the first observation of disease progression or death due to any cause during or after the treatment period, whichever occurs first.

  • Overall Survival (OS) [ Time Frame: up to 55 months ] [ Designated as safety issue: No ]
    Overall survival (OS) was defined as the time from randomization to death of any cause.


Enrollment: 104
Study Start Date: October 2009
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Arm 1

Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily

Subjects will continue treatment until disease progression or unacceptable toxicity

Drug: lenalidomide

Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows:

  • Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily
  • Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily
  • Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity
Active Comparator: Treatment Arm 2

Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily

Subjects will continue treatment until disease progression or unacceptable toxicity

Drug: lenalidomide

Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows:

  • Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily
  • Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily
  • Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity
Active Comparator: Treatment Arm 3

Treatment Arm 3: 15 mg →20 mg →25 mg/daily

Subjects will continue treatment until disease progression or unacceptable toxicity

Drug: lenalidomide

Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows:

  • Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily
  • Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily
  • Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years at the time of signing the informed consent form
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Must have a documented diagnosis of B-cell CLL
  • Must be relapsed or refractory to at least 1 regimen for treatment of CLL . At least one of the prior treatments must have included a purine analog-based or bendamustine-based regimen
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.

Exclusion Criteria:

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
  • Active infections requiring systemic antibiotics
  • Systemic treatment for B-cell CLL within 28 days of initiation of lenalidomide treatment
  • Alemtuzumab therapy within 120 days of initiating lenalidomide treatment
  • Prior therapy with lenalidomide
  • History of grade 4 rash due to prior thalidomide treatment
  • Planned autologous or allogeneic bone marrow transplantation
  • Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.
  • Uncontrolled hyperthyroidism or hypothyroidism
  • Venous thromboembolism within 12 months
  • ≥ Grade-2 neuropathy
  • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
  • Disease transformation [i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia]
  • Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating lenalidomide therapy
  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: NCT00963105

  Hide Study Locations
Locations
United States, California
UCSD Moores Cancer Center
La Jolla, California, United States, 92093-0820
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, United States, 92270
Stanford University School of Medicine
Stanford, California, United States, 94305-5821
United States, Connecticut
Cancer Center of Central Connecticut
Southington, Connecticut, United States, 06489
United States, Florida
Cancer and Blood Disease Center
Lecanto, Florida, United States, 34461
United States, Illinois
Northwestern University Medical Center Division of Hematology Oncology
Chicago, Illinois, United States, 60611-2927
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5149
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Long Island Jewish Medical Center CLL Research and Treatment Program
New Hyde Park, New York, United States, 11042
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Drexel University, College of Medicine, Clinical Research Group
Philadelphia, Pennsylvania, United States, 19102
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
France
CHU Sud
Amiens, France, 80054
Hopital Avicenne
Bobigny Cedex, France, 93009
CHU Grenoble
Grenoble Cedex 09, France, 38043
Clinique Victor Hugo
Le Mans, France, 72000
Institut Paoli Calmettes
Marseille Cedex 9, France, 13273
CHU Montpellier - Hôpital Saint Eloi
Montpellier Cedex 5, France, 34295
Hopital Emile Muller
Mulhouse, France, 68000
Hopital Pitie Salpetriere
Paris, France, 75651
CH Perpignan - Hopital Saint-Jean
Perpignan, France, 66046
CHRU - Hopital du Haut Leveque
Pessac, France, 33604
Centre Hospitalier Lyon Sud
Pierre Bénite, France, 69310
Hopital Robert Debre
REIMS cedex, France, 51092
CHU Rennes Hematology
Rennes cedex, France, 35033
CHRU Hopital Brabois
Vandoeuvre les Nancy, France, 54511
Germany
Charite -Universitätsmedizin Berlin
Berlin, Germany, 13353
Universitatsklinikum Essen
Essen, Germany, 45122
Ernst-Moritz-Arndt-Universität Greifswald
Greifswald, Germany, 17487
Universitatsklinikum Schleswig Holstein
Kiel, Germany, 24116
Klinikum der Universitat zu Koln
Köln, Germany, 50924
University of Ulm Abteilung Innere Medizin III
Ulm, Germany, 89081
Italy
Azienda Ospedaliera Universitaria San Martino
Genova, Italy, 16132
Ematologia ed Immunologia, Azienda Ospedaliera "Vito Fazzi" di Lecce
Lecce, Italy, 73100
I.R.C.C.S. Ospedale San Raffaele
Milano, Italy, 20132
Istituto Europeo di Oncologia - IEO
Milano, Italy, 20141
Universita degli Studi di Padova
Padova, Italy, 35128
Universita' Degli Studi Di Perugia
Perugia, Italy, 06100
Spain
Hospital Universitari Germans Trias i Pujol
Badalona. Barcelona, Spain, 08916
Hospital Clinic Provincial de Barcelona
Barcelona, Spain, 08036
Sweden
Karolinska Universitetssjukhuset
Stockholm, Sweden, 14186
United Kingdom
St James's Institute of Oncology
Leeds, United Kingdom, LS9 7TF
St.Bartholomew's Hospital
London, United Kingdom, EC1M 6BQ
King's College Hospital
London, United Kingdom, SE5 9RS
The Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Christie Hospital NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Kenichi Takeshita, M.D., MPH Celgene Corporation
  More Information

Publications:
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00963105     History of Changes
Other Study ID Numbers: CC-5013-CLL-009 
Study First Received: August 20, 2009
Last Updated: July 7, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 24, 2016