Lenalidomide in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Small Lymphocytic Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439231
• Other study ID #: 070104
• Secondary ID: 07-H-0104
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2007
• Last updated: November 14, 2013
• Start date: February 2007
• Est. completion date: November 2010

Study information

• Verified date: November 2013
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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 partial response (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.

Other known NCT identifiers

• NCT00465127

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

• 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.

Study Design

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia (CLL)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Small Lymphocytic Lymphoma

Intervention

Drug:
• Lenalidomide
Lenalidomide (Revlimid) regimen testing to determine efficacy for SLL/ CLL subjects

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Georg Aue, M.D.	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen	To establish the overall response rate based on peripheral blood measures (absolute neutrophil count, platelets, and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after first dose of lenalidomide using this dosing regimen	24 weeks of lenalidomide therapy	No

External Links

•   NIH Clinical Center Detailed Web Page