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Evaluation of the Immune Restoration Potential Of Lenalidomide

NCT02371577 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-04-28

No results posted yet for this study

Summary

This is phase 2 study of the immunomodulatory drug, lenalidomide, to evaluate potential beneficial effects on the immune system of patients with chronic lymphocytic leukemia (CLL) and CLL-associated immunodeficiency. 17 patients will be enrolled with CLL, small lymphocytic lymphoma (SLL), or monoclonal B-cell lymphocytosis (MBL), and measurable immune compromise, but not an iwCLL indication for CLL therapy (ie non-progressive disease).

Conditions

  • Chronic Lymphocytic Leukemia (CLL)

Interventions

DRUG

Lenalidomide

Lenalidomide is administered orally once daily on Days 8-28 of each 28 day cycle. The typical starting dose is 2.5mg PO daily. At the start of each cycle, there is intra-patient dose-escalation to a maximum of 25mg daily, in the absence of grade 2 or higher adverse events Duration of lenalidomide on the clinical trial is for up to 6 cycles, each of 28 day duration.

Sponsors & Collaborators

Principal Investigators

  • Michael Choi, MD · UC San Diego Moores Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2018-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT02371577 on ClinicalTrials.gov