Lenalidomide Therapy for Patients With Relapsed and/or Refractory, Peripheral T-Cell Lymphomas

Anaplastic Large Cell Lymphoma Clinical Trial

Official title: Open-Label, One Arm Pilot Investigation of Lenalidomide Therapy for Patients With Relapsed and/or Refractory, Peripheral T-Cell Lymphomas

Status Terminated

Clinical Trial Summary

The purpose of this study is to:

• assess the effectiveness of lenalidomide for the treatment of patients with relapsed and or refractory peripheral T-cell lymphomas; and,

• assess the safety of lenalidomide.

There are reports suggesting a therapeutic benefit of thalidomide in patients with refractory and/or relapsed Non-Hodgkin's Lymphoma's (NHL) which have led to the formal investigation of lenalidomide in the treatment of relapsed NHL's.

Clinical Trial Description

Peripheral T-cell lymphomas (PTCL's) represent a subgroup of Non-Hodgkin's lymphomas with poor prognostic features. Compared to aggressive B-cell lymphomas, PTCL's often present with more advanced disease and sustain less durable remissions following treatment with chemotherapy. With standard anthracycline-based regimens such as CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), PTCLs achieve inferior 5-year overall survival rates of around 40% compared to aggressive B-cell lymphomas whose 5-year overall survival rates reach 50-60%. While several salvage regimens have been established for B-cell lymphomas with moderate success, the guidelines for patients with relapsed and/or refractory PTCL's are less clear. Several reports suggest that the immunomodulatory drugs (IMiDs®) have clinical activity in this setting. The aim of this phase 2 study is to evaluate the activity of lenalidomide in relapsed and/or refractory PTCL's. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult T-cell Leukemia
• Adult T-cell Lymphoma
• Anaplastic Large Cell Lymphoma
• Angioimmunoblastic T-cell Lymphoma
• Cutaneous t-Cell Lymphoma With Nodal/Visceral Disease
• Leukemia, T-Cell
• Leukemia-Lymphoma, Adult T-Cell
• Lymphoma
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Lymphoma, T-Cell, Peripheral
• Peripheral T-cell Lymphoma Unspecified
• Peripheral T-cell Lymphomas
• T/Null Cell Systemic Type

• NCT number: NCT00704691
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Status: Terminated
• Phase: Phase 0
• Start date: June 2008
• Completion date: December 2009