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Spots Global Cancer Trial Database for Lenalidomide in Treating Patients With High-Risk Chronic Lymphocytic Leukemia

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Lenalidomide in Treating Patients With High-Risk Chronic Lymphocytic Leukemia

Official Title: Lenalidomide for the Treatment of CLL Patients With High-Risk Disease

Study ID: NCT01271283

Study Description

Brief 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.

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Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Roswell Park Cancer Institute, Buffalo, New York, United States

Contact Details

Name: Asher Chanan-Khan

Affiliation: Roswell Park Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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