A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
NCT ID: NCT00655668
Last Updated: 2019-11-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
54 participants
INTERVENTIONAL
2008-03-01
2010-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
NCT00179673
A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma
NCT00413036
Safety And Efficacy Of Lenalidomide In Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma (NHL)
NCT00179660
Phase II Study of Lenalidomide for the Treatment of Relapsed or Refractory Hodgkin's Lymphoma
NCT00478959
Lenalidomide Therapy for Patients With Relapsed and/or Refractory, Peripheral T-Cell Lymphomas
NCT00704691
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lenalidomide
Open-label, oral lenalidomide monotherapy
Lenalidomide
Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lenalidomide
Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Celgene
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kenichi Takeshita, MD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Hôpital Claude Huriez
Place de Verdun Cedex, Lille, France
Hôpital Lapeyronie
Cedex, Montpellier, France
Centre Hospitalier Lyon Sud
Lyon Sud, Pierre-Bénite, France
CHRU Hôpitaux de Brabois - Hématologie
Vandœuvre-lès-Nancy, Rue Morvan Cedex, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Hôtel Dieu Pavillon Villemur Pasteur
Clermont-Ferrand, , France
Hopital Henri Mondor
Créteil, , France
CHU de Dijon
Dijon, , France
Hopital Michallon
Grenoble, , France
CHD Les Oudairies
La Roche-sur-Yon, , France
CHU Dupuytren
Limoges, , France
Hôpital N.D.de Bon Secours
Metz, , France
Hôpital Saint-Louis
Paris, , France
Hôpital Necker
Paris, , France
Hôpital de la Pitié Salpétriere
Paris, , France
CHU Rennes Hôpital Pontchaillou
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Centre René Huguenin
Saint-Cloud, , France
Hôpital Purpan
Toulouse, , France
Centre Hospitalier
Valence, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, Glaisner S, Gabarre J, Bosly A, Lister J, Li J, Coiffier B. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: the EXPECT trial. Eur J Cancer. 2013 Sep;49(13):2869-76. doi: 10.1016/j.ejca.2013.04.029. Epub 2013 May 31.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2007-002171-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-5013-TCL-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.