A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma
1. Understand and voluntarily sign an informed consent form.
2. Age greater than or equla to18 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. Indolent lymphoma the following histologies are acceptable: a. Follicular center
lymphoma, grades 1, 2, b. Extranodal marginal zone B-cell lymphoma of MALT type, c.
Nodal marginal zone B-cell lymphoma d. Splenic marginal zone B-cell lymphoma, e.
Small lymphocytic lymphoma, f. Lymphoplasmacytoid lymphoma
6. Relapsed or refractory to previous therapy for lymphoma. Subjects 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. Subjects 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 (see
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.
1. Any of the following laboratory abnormalities
1. Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)
2. Platelet count <100,000/mm3 (100 x 109/L)
3. Serum creatinine >2.5 mg/dL (221 mmol/L)
4. Serum SGOT/AST or 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 subjects with 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, CT scan or MRI, for at least
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 HIV.
7. Pregnant or lactating females.
8. Prior > or equal to grade 3 (Appendix III: NCI CTCAE) allergic
reaction/hypersensitivity to thalidomide.
9. Prior > or equal to³ grade 3 (Appendix III: 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.