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A Phase II Study of Lenalidomide Revlimid(Registered Trademark) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma


Phase 2
21 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Anemia, Small Lymphocytic Lymphoma

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Trial Information

A Phase II Study of Lenalidomide Revlimid(Registered Trademark) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma


There is evidence that lenalidomide has single agent activity in chronic lymphocytic
leukemia (CLL)/small lymphocytic leukemia (SLL. Optimal dosing of lenalidomide in CLL has
not been established yet. A pilot clinical trial in CLL studied single agent lenalidomide
cycled every 4 weeks with 25 mg for three weeks on and one week off drug. In this trial dose
reductions have been necessary secondary to prolonged neutropenia or thrombocytopenia in a
majority of patients. However, there was also remarkable efficacy and evidence for an immune
stimulatory effect of lenalidomide. Therefore, we propose this phase II trial using 20 mg
lenalidomide (Revlimid(Registered Trademark)) 3 weeks on and 3 weeks off for 4 cycles in
subjects who have been previously treated for chronic lymphocytic leukemia (CLL)/small
lymphocytic leukemia (SLL). Subjects with at least PR may go on to receive 4 additional
cycles.

The primary objective of the trial is to test the efficacy of a more tolerable dosing scheme
of lenalidomide.

Inclusion 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/mcL.

4. Platelet count greater than or equal to 20K/mcL.

5. Age 21-99.

EXCLUSION CRITERIA:

1. Chronic or current clinically significant infection, including HIV positivity or
uncontrolled infection.

2. 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The response rate to lenalidomide (Revlimid) in subjects with CLL/SLL.

Authority:

United States: Federal Government

Study ID:

070104

NCT ID:

NCT00439231

Start Date:

February 2007

Completion Date:

November 2010

Related Keywords:

  • Chronic Lymphocytic Anemia
  • Small Lymphocytic Lymphoma
  • Monoclonal Antibody Therapy
  • Biologic Response Modifier Therapy
  • CLL
  • SLL
  • CC 5013
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Leukemia
  • Anemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892