Protocol Number: 07-H-0104

Title:

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

Number:

07-H-0104

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.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

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) 500/mcL.

4. Platelet count 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.

Special Instructions:

Currently Not Provided

Keywords:

Monoclonal Antibody Therapy

Biologic Response Modifier Therapy

CLL

SLL

CC 5013

Recruitment Keyword(s):

Chronic Lymphocytic Leukemia

CLL

Small Lymphocytic Leukemia

SLL

Condition(s):

Chronic Lymphocytic Anemia

Small Lymphocytic Lymphoma

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Drug: Lenalidomide (Revlimide)

Supporting Site:

National Heart, Lung and Blood Institute

Contact(s):

Georg Aue, M.D.
National Institutes of Health
Building 10
Room 3-5256
10 Center Drive
Bethesda, Maryland 20892-1202
Phone: (301) 451-7141
Fax: (301) 594-1290
Electronic Address: aueg@mail.nih.gov

Citation(s): Not Provided

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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