Trials / Withdrawn
WithdrawnNCT01271283
Lenalidomide in Treating Patients With High-Risk Chronic Lymphocytic Leukemia
Lenalidomide for the Treatment of CLL Patients With High-Risk Disease
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II clinical trial is studying how well lenalidomide works in treating patients with high-risk chronic lymphocytic leukemia. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.
Detailed description
PRIMARY OBJECTIVES: I. To determine the time to progression in patients with high-risk chronic lymphocytic leukemia (CLL) treated with lenalidomide. SECONDARY OBJECTIVES: I. To determine the clinical response (complete and partial response) in treatment-naïve patients with high-risk CLL treated with single-agent lenalidomide. II. To determine the incidence of immune-mediated flare reaction. III. To determine the toxicity profile of single-agent lenalidomide in previously untreated patients with high-risk CLL. IV. To conduct correlative studies in bone marrow, peripheral blood, and/or lymph nodes of patients treated with lenalidomide. OUTLINE: Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (by morphological criteria but have persistent minimal residual disease by molecular criteria) or partial response may continue treatment beyond 8 courses. Patients may undergo bone marrow, peripheral blood, and/or lymph node sample collection at baseline and periodically during study for correlative studies. After completion of study therapy, patients are followed up every 3 months for a maximum of 5 years.
Conditions
- Chronic Lymphocytic Leukemia
- Stage III Chronic Lymphocytic Leukemia
- Stage IV Chronic Lymphocytic Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Diagnostic Laboratory Biomarker Analysis | Correlative studies |
| DRUG | Lenalidomide | Given orally |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2011-08-01
- Completion
- 2011-08-01
- First posted
- 2011-01-06
- Last updated
- 2015-06-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01271283. Inclusion in this directory is not an endorsement.