Safety And Efficacy Of Lenalidomide In Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma (NHL)
Condition: Non-Hodgkins Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Lenalidomide
Intervention description: Capsules for oral administration.
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: celgene; cc-5013; CC5013; NHL; Non-Hodgkins Lymphoma; Revlimid

Summary:

      To determine the activity of lenalidomide in relapsed or refractory aggressive NHL.
    

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

          5. Aggressive lymphoma, the following histologies are acceptable: Follicular center
             lymphoma, grade 3, Diffuse large cell, Mantle cell, Transformed

          6. Relapsed or refractory to previous therapy for lymphoma. Patients 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. Patients 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. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy
             test within 7 days of starting study drug. In addition, sexually active WCBP must
             agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal
             contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with
             spermicide; or vasectomized partner) while on study drug.

        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 aspartate transaminase (AST) or alanine transaminase (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 patients with central nervous system (CNS) disease with the exception of those
             patients 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 (CT) scan or magnetic resonance imaging (MRI), for at least 6
             months.

          4. Prior history of malignancies other than non-Hodgkin's lymphoma (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 > or equal to grade 3 National Cancer Institute Common Terminology Criteria for
             Adverse Events (NCI CTCAE) allergic reaction/hypersensitivity to thalidomide

          9. Prior > or equal to grade 3 NCI CTCAE 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