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 2, 2014
Last verified: July 2014

August 20, 2009
July 2, 2014
July 2009
August 2014   (final data collection date for primary outcome measure)
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
Safety [type, frequency, and severity of adverse events (AEs) and relationship of AEs to lenalidomide] [ Time Frame: 24 months post LPFV ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00963105 on ClinicalTrials.gov Archive Site
  • 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.
  • Response rate [per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines for diagnosis and treatment of CLL (Hallek, 2008)] [ Time Frame: 24 months post LPFV ] [ Designated as safety issue: No ]
  • Duration of response, Time to response, Time to progression, Event-free survival, Progression-free survival, Overall survival [ Time Frame: 24 months post LPFV ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
A Phase II, Multi-center, Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of Different Lenalidomide (Revlimid) Dose Regimens in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsed or Refractory Chronic Lymphocytic Leukemia
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 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

    Intervention: Drug: lenalidomide
  • 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

    Intervention: Drug: lenalidomide
  • 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

    Intervention: Drug: lenalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
103
August 2017
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Germany,   Italy,   Spain,   Sweden,   United Kingdom
 
NCT00963105
CC-5013-CLL-009
Yes
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Jay Mei, M.D. Celgene Corporation
Celgene Corporation
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP