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Lenalidomide as Immune Adjuvant in Patient's With Chronic Lymphocytic Leukemia (CLL)

NCT01924169 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-09-20

Study results available
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Summary

The goal of this clinical research study is to learn if lenalidomide can increase the level of immunoglobulins (parts of the blood that may help to improve the immune system's function) and/or will improve the protective effect of the flu and pneumonia vaccines in patients with CLL.

Conditions

  • Hematologic Disorder

Interventions

DRUG

Lenalidomide

5 mg/day by mouth on Monday, Wednesday and Friday for 3 months. Process repeated for up to 2 years. If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day by mouth for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.

BIOLOGICAL

Influenza Vaccine

Administered as injection yearly, during the fall/winter season.

BIOLOGICAL

Pneumovax Vaccine

Administered by injection once between month 6 and month 21. Patients, who have received the Pneumovax vaccine within last 5 years, will not receive Pneumovax vaccination.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Alessandra Ferrajoli, MD,BS · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-24
Primary Completion
2017-02-21
Completion
2017-02-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT01924169 on ClinicalTrials.gov