Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene Corporation
• Collaborator: Prologue Research International
• Treatments: Lenalidomide; Thalidomide

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.