A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma

Stopped early · Phase 2

Conditions studied: T-cell Non-Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID

NCT00655668

Run by

Celgene

People needed

54

Starts

2008-03-01

Expected to finish

2010-04-01

Last updated by the study team

2019-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Cutaneous T-cell Lymphoma of subtype Sézary Syndrome.

Where it is running

• Tower Cancer Research Foundation — Beverly Hills, California, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Western Pennsylvania Hospital — Pittsburgh, Pennsylvania, United States
• The Canberra Hospital Building 3, L 2 — Garran, Australian Capital Territory, Australia
• Cancer Therapy Centre — Liverpool, New South Wales, Australia
• Clinical Research Unit Cairns Base Hospital — Cairns, Queensland, Australia
• The Townsville Hospital — Douglas, Queensland, Australia
• Royal Brisbane & Women's Hospital — Herston, Queensland, Australia
• Ashford Cancer Centre — Ashford, South Australia, Australia
• Royal Adelaide Hospital L3 East Wing — North Terrace, South Australia, Australia
• Royal Hobart Hospital — Hobart, Tasmania, Australia
• Box Hill Hospital, 4th Floor, Clive Ward Centre — Box Hill, Victoria, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• Peter MacCallum Cancer Centre — East Melbourne, Victoria, Australia
• St Vincents Hospital — Fitzroy, Victoria, Australia
• Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
• Institute Jules Bordet — Brussels, Belgium
• Cliniques Universitaires St Luc — Brussels, Belgium
• KUL — Leuven, Belgium
• Clinique St Pierre — Ottignies, Belgium
• Cliniques universitaires UCL de Mont-Godinne — Yvoir, Belgium
• CHU Hôtel Dieu — Nantes, Cedex 01, France
• Hôpital Bretonneau — Tours, Cédex 1, France
• CHU Hôpital Hôtel Dieu — Angers, Cédex 9, France

Full record on ClinicalTrials.gov

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