A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
Status:
Terminated
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide
monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study
will be conducted in two phases: a Treatment Phase and a Follow-up Phase.
Subjects who qualify for enrollment into the study will enter the Treatment Phase and receive
single-agent lenalidomide 25 mg once daily on Days 1-21 every 28 days (28-day cycles).
Subjects may continue participation in the Treatment Phase of the study for a maximum
duration of 24 months, or until disease progression or unacceptable adverse events develop.
All subjects who discontinue the Treatment Phase for any reason will continue to be followed
until progression of disease or until next lymphoma treatment is given, whichever comes
first, during the Follow-up Phase.
Objectives:
Primary:
• To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell
Non-Hodgkin's Lymphoma (NHL). Efficacy will be assessed by measuring the response rate, tumor
control rate, duration of response, time to progression and progression free survival.
Secondary:
• To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed
or refractory T-cell NHL.