Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Celgene Corporation |
---|---|
Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00655668 |
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 AEs 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 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.
Condition | Intervention | Phase |
---|---|---|
Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma |
Drug: lenalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®) in Subjects With Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 80 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Biopsy-proven T-cell non-Hodgkin's lymphoma, either:
Exclusion Criteria:
Responsible Party: | Celgene Corporation ( Helen Joahnsen ) |
Study ID Numbers: | CC-5013-TCL-001 |
Study First Received: | April 4, 2008 |
Last Updated: | April 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00655668 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Belgium: Federal Agency for Medicinal Products and Health Products |
Lymphatic Diseases Immunoproliferative Disorders Lymphoma, T-Cell Lenalidomide |
Lymphoma, small cleaved-cell, diffuse Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |