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Lenalidomide in HTLV-1 Adult T-Cell Leukemia

NCT01274533 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2016-05-23

Study results available
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Summary

This is a research study for subjects who have been diagnosed with Adult T cell Leukemia/Lymphoma, a rare and aggressive peripheral T cell neoplasm caused by the virus HTLV1. Currently, there is no accepted standard therapy for this disease. The purpose of this research study is to evaluate the use of the investigational drug lenalidomide in the treatment of Adult T cell Leukemia/Lymphoma.

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.

Conditions

  • Adult T Cell Leukemia/Lymphoma

Interventions

DRUG

Lenalidomide

25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle

Sponsors & Collaborators

Principal Investigators

  • Adrienne A Phillips, MD, MPH · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-01-31
Completion
2013-05-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01274533 on ClinicalTrials.gov