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

NCT ID: NCT00439231

Last Updated: 2014-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2010-11-30

Brief 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.

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Detailed 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.

Conditions

Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenalidomide (Revlimid) subjects

Lenalidomide regimen testing to determine efficacy for CLL/ SLL subjects

Group Type: EXPERIMENTAL

Lenalidomide

Intervention Type: DRUG

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

Interventions

Lenalidomide

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

Intervention Type: DRUG

Other Intervention Names

Revlimid

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Georg Aue, M.D.

NIH

Sponsor Role: lead

Responsible Party

Georg Aue, M.D.

NHLBI Hematolgy Clinician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Georg Aue, MD

Role: PRINCIPAL_INVESTIGATOR

NIH National Heart, Lung and Blood Institute

Locations

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Countries

United States

References

Aue G, Nelson Lozier J, Tian X, Cullinane AM, Soto S, Samsel L, McCoy P, Wiestner A. Inflammation, TNFalpha and endothelial dysfunction link lenalidomide to venous thrombosis in chronic lymphocytic leukemia. Am J Hematol. 2011 Oct;86(10):835-40. doi: 10.1002/ajh.22114. Epub 2011 Aug 2.

Reference Type: DERIVED

PMID: 21812019 (View on PubMed)

Related Links

http://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2007-H-0104.html

NIH Clinical Center Detailed Web Page

Other Identifiers

07-H-0104

Identifier Type: OTHER

Identifier Source: secondary_id

070104

Identifier Type: -

Identifier Source: org_study_id

NCT00465127

Identifier Type: -

Identifier Source: nct_alias