Lenalidomide in HTLV-1 Adult T-Cell Leukemia
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Lenalidomide in Patients With Relapsed or Refractory HTLV-1 Associated Adult T Cell Leukemia/Lymphoma|
- Response rate (CR + Cru + PR) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Peripheral blood, CT or MRI
- Safety of lenalidomide monotherapy [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.
25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle
Other Name: Revlimid
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274533
|Contact: Herbert Irving Comprehensive Cancer Center Clinical Research Management Office||212-305-8615|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Principal Investigator: Adrienne A Phillips, MD, MPH|
|Sub-Investigator: Michael Flamm, MD, PhD|
|Sub-Investigator: David Diuguid, MD|
|Sub-Investigator: J. Gregory Mears, MD|
|Principal Investigator:||Adrienne A Phillips, MD, MPH||Columbia University|