Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
Condition: Non-Hodgkins Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Lenalidomide
Intervention description: Lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NHL; CC5013; Non-Hodgkins Lymphoma; revlimid; cc-5013; celgene

Summary:

      Participants who qualify will receive lenalidomide daily on days 1-21 of every 28 day cycle.
      Treatment will continue for up to 52 weeks or until disease progression; participants who
      achieve a complete response (CR) will receive an additional 2 cycles of treatment prior to
      discontinuation. Participants will be followed for progression free survival following
      discontinuation from the treatment phase
    

Eligibility criteria:

        Inclusion Criteria:

          1. Understand and voluntarily sign an informed consent form.

          2. Age greater than or equal to 18 years at the time of signing the informed consent form

          3. Able to adhere to the study visit schedule and other protocol requirements

          4. Biopsy-proven non-Hodgkin's lymphoma (NHL)

          5. Indolent lymphoma the following histologies are acceptable:

               1. Follicular center lymphoma, grades 1, 2,

               2. Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
                  (MALT) type,

               3. Nodal marginal zone B-cell lymphoma

               4. Splenic marginal zone B-cell lymphoma,

               5. Small lymphocytic lymphoma,

               6. Lymphoplasmacytoid lymphoma

          6. Relapsed or refractory to previous therapy for lymphoma. Participants must have
             received at least one prior treatment regimen such as radiation, immunotherapy,
             chemotherapy, OR radioimmunotherapy, and be ineligible or unwilling to undergo an
             autologous stem cell transplant. There is no limit on the number of prior therapies

          7. Participants must have measurable disease on cross sectional imaging that is at least
             2 cm in the longest diameter

          8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2

          9. Females of childbearing potential (FCBP) must agree to use two reliable forms of
             contraception or to practice complete abstinence from heterosexual intercourse during
             the following periods 1) for at least 28 days before starting study drug; 2) while
             participating in the study; and 3) for at least 28 days after discontinuation from the
             study. The two methods of reliable contraception must include one highly effective
             method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or
             implants], tubal ligation, partner's vasectomy) and one additional effective (barrier)
             method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a
             qualified provider of contraceptive methods if needed.

        Exclusion Criteria:

          1. Any of the following laboratory abnormalities

               1. Absolute neutrophil count (ANC) <1,500 cells/mm^3 (1.5 x 10^9/L)

               2. Platelet count <100,000/mm^3 (100 x 10^9/L)

               3. Serum creatinine >2.5 mg/dL (221 mmol/L)

               4. Serum glutamic-oxaloacetic transaminase/ aspartate aminotransferase (SGOT/AST) or
                  serum glutamic:pyruvic transaminase/alanine aminotransferase (SGPT/ALT) >5.0 x
                  upper limit of normal (ULN)

               5. Serum total bilirubin >2.0 mg/dL (34 mmol/L)

          2. Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study.

          3. All participants with Central Nervous System (CNS) disease with the exception of those
             subjects whose CNS disease has been treated with chemotherapy, radiotherapy or surgery
             and remains asymptomatic, with no active CNS disease, as shown by lumbar puncture,
             Computed Tomography or Magnetic resonance imaging (CT scan or MRI), for at least 6
             months.

          4. Prior history of malignancies other than NHL (except for basal cell or squamous cell
             carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject
             has been free of the disease for > or equal to 1 year.

          5. Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          6. Known positive for Human Immunodeficiency Virus (HIV).

          7. Pregnant or lactating females.

          8. Prior ≥ grade 3 (National Cancer Institute-Common Terminology Criteria for Adverse
             Events [NCI CTCAE]) allergic reaction/hypersensitivity to thalidomide.

          9. Prior ≥ grade 3 rash or any desquamating (blistering) rash while taking thalidomide.

         10. Prior use of lenalidomide.

         11. Use of any standard or experimental anti-cancer drug therapy within 28 days of day 1
             of study drug therapy.

         12. Known active Hepatitis C.