NCT01274533

Lenalidomide in HTLV-1 Adult T-Cell Leukemia

A Phase II Study of Lenalidomide in Patients With Relapsed or Refractory HTLV-1 Associated Adult T Cell Leukemia/Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Primary Objective is to determine the efficacy of lenalidomide monotherapy in relapsed or refractory HTLV 1 associated Adult T Cell Leukemia/Lymphoma. Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival. The Secondary Objective is to evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory HTLV 1 associated Adult T Cell Leukemia/Lymphoma.

Conditions

• Adult T Cell Leukemia/Lymphoma

Interventions

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

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-01-01
• Completion: 2013-05-01
• First posted: 2011-01-11
• Last updated: 2016-05-23
• Results posted: 2016-04-22

Locations

1 site across 1 country: United States