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Lenalidomide in Patients With Chronic Lymphocytic Leukemia Older Than 65 Years of Age

NCT01011894 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-05-18

Study results available
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Summary

The purpose of this study is to:

Determine the likelihood that lenalidomide will adequately control the disease for at least one year.

Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions.

In this case it is considered experimental. The lenalidomide being administered in this study is not a commercially marketed product. Although it is expected to be very similar in safety and activity to the commercially marketed drug, it is possible that some differences may exist. Because this is not a commercially marketed drug, lenalidomide can only be administered to patients enrolled in this clinical trial and may only be administered under the direction of physicians who are investigators in this clinical trial.

Conditions

Interventions

DRUG

lenalidomide

Lenalidomide will be administered orally at a starting dose of 2.5mg once daily, days 1-28. Patients will be evaluated prior to treatment and at 4 weeks, 8 weeks, 12 weeks, 16 weeks and at a minimum of 4 weeks thereafter until removal from study. Patients with stable disease or better will continue at their current dose unless they experience toxicity requiring dose reduction. For those patients who have progressive disease on their current dose and have no dose-limiting toxicity, their dose will be increased from 2.5mg, to 5mg, to 10mg, to 15mg, to 20mg one dose level at a time not more frequently than once every 4 weeks. The maximum dose will be 20mg.

Sponsors & Collaborators

Principal Investigators

  • Renier Brentjens, MD, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-06
Primary Completion
2016-02-23
Completion
2016-02-23

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01011894 on ClinicalTrials.gov