Lenalidomide in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Condition: Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Lenalidomide
Intervention description: Lenalidomide (Revlimid) regimen testing to determine efficacy for SLL/ CLL subjects
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Monoclonal Antibody Therapy; Biologic Response Modifier Therapy; CLL; SLL; chemo-care (CC) 5013- Revlimid; Chronic Lymphocytic Leukemia; Small Lymphocytic Leukemia

Summary:

      This study will evaluate the safety and effectiveness of a new drug called lenalidomide
      (Revlimid) for treating patients with chronic lymphocytic leukemia (CLL) and small
      lymphocytic lymphoma (SLL) who relapsed after their initial treatment.

      Patients 21 years of age and older with CLL or SLL who have previously received standard
      treatment may be eligible for this study.

      Participants take lenalidomide capsules once a day for 21 days, followed by 21 days off the
      drug. This constitutes one treatment cycle. Treatment continues for four cycles as long as
      the medicine is tolerated. After four cycles, patients who respond completely continue
      treatment for another two cycles; patients who respond partially continue treatment for
      another four cycles; and patients who do not respond stop treatment but continue to be
      followed for safety.

      ...
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

               1. Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia
                  (SLL).

               2. Failed prior standard of care therapy for CLL.

               3. Neutrophil count (ANC) greater than or equal to 500/microliter (mcL).

               4. Platelet count greater than or equal to 20,000/mcL.

               5. Age 21-99.

        EXCLUSION CRITERIA:

          1. Chronic or current clinically significant infection, including HIV positivity or
             uncontrolled infection.

          2. Eastern Cooperative Oncology Group (ECOG) performance greater than 2.

          3. Other concurrent anticancer therapies.

          4. Less than 4 weeks from last systemic therapy for CLL. Steroids up to 2 weeks before
             the start of treatment are permissible.

          5. Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary,
             infectious, or metabolic disease of such severity that it would preclude the patient's
             ability to tolerate protocol therapy.

          6. Creatinine greater than 1.5 times the upper limit of normal.

          7. Women who are pregnant or nursing, as well as women of childbearing potential who are
             unwilling to use a dual method of contraception.

          8. Men who are unwilling to use a barrier protection.

          9. Inability to understand the investigational nature of the study; inability to provide
             informed consent.