CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled
Drug / intervention
Lenalidomidedrug
Likely dose
Lenalidomide 25mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01274533
NCT01274533Phase 2Completed

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

Columbia University·interventional·Posted Jan 11, 2011·Updated May 23, 2016

In Brief

A Phase 2 clinical trial evaluating Lenalidomide for Adult T Cell Leukemia/Lymphoma. Completed, enrolled 4 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsCelgene Corporation

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 11, 2011
Enrollment StartDec 1, 2010
Primary CompletionJan 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.5 years ago

Interventions

Lenalidomidedrug

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