Clinical trial NCT00439231: Lenalidomide in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Official title: A Phase II Study of Lenalidomide Revlimid(Registered Trademark) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma
Keywords: Monoclonal Antibody Therapy
Biologic Response Modifier Therapy
CLL
SLL
chemo-care (CC) 5013- Revlimid
Chronic Lymphocytic Leukemia
Small Lymphocytic Leukemia
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2007-02-23
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

...

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.

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.

Primary outcomes:
measure: To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen
timeFrame: 24 weeks of lenalidomide therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: NIH National Heart, Lung and Blood Institute
name: Georg Aue, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.