Status:
TERMINATED
A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
Lead Sponsor:
Celgene
Conditions:
T-cell Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Study was terminated. Study data assessment revealed that study drug is active, but is not likely to be sufficiently active as a single agent in this population for registration purposes.
Eligibility Criteria
Inclusion
- Must understand and voluntarily sign an informed consent form.
- Must be ≥ 18 years of age at the time of signing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Biopsy-proven T-cell Non-Hodgkin's Lymphoma, either:
- Peripheral T-cell Lymphoma (PTCL) whatever the subtype, or
- Cutaneous T-cell Lymphoma (CTCL), but only the subtype mycosis fungoides.
- Relapsed or refractory to previous therapy for T-cell Non-Hodgkin's Lymphoma.
- Must have received at least one prior combination chemotherapy regimen. There is no limit on the number of prior therapies.
Exclusion
- Cutaneous T-cell Lymphoma of subtype Sézary Syndrome.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00655668
Start Date
March 1 2008
End Date
April 1 2010
Last Update
November 25 2019
Active Locations (45)
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1
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211-1850
2
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
3
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
4
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224