Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Condition: Relapsed or Refractory Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: lenalidomide
Intervention description: 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
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and effectiveness of different dose
      regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia
      (CLL).
    

Eligibility 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