NCT01207921

Lenalidomide Maintenance Therapy Post Autologous Transplant for Hodgkins Lymphoma

A Pilot Study of Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplantation in Patients With Relapsed/Refractory Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study to evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after autologous transplant

Detailed description

Primary Objectives -To evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after autologous stem cell transplant, as measured by dropout rate. Secondary Objectives * To assess overall survival, event free survival, and progression free survival. * To establish the adverse event profile of long-term maintenance therapy with lenalidomide in this patient population. * To assess the conversion of partial response/stable disease post-ASCT to complete response. * To evaluate changes in immune cell number and function and plasma proteins before, during, and after lenalidomide therapy (correlative studies).

Conditions

• Hodgkin Disease

Interventions

Type	Name	Description
DRUG	Lenalidomide

Timeline

• Start date: 2011-04-28
• Primary completion: 2016-09-19
• Completion: 2021-03-05
• First posted: 2010-09-23
• Last updated: 2021-03-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study