Study Stopped
Decision not to pursue as single agent in the study population.
A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
EXPECT
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
2 other identifiers
interventional
54
4 countries
45
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2008
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 4, 2008
CompletedFirst Posted
Study publicly available on registry
April 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
January 5, 2012
CompletedNovember 25, 2019
November 1, 2019
2 years
April 4, 2008
November 30, 2011
November 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participants Categorized by Best Response as Determined by Investigator
Participant response assessed by investigator; criteria by B. Cheson in Journal of Clinical Oncology, 1999 (see article for more detail): * Complete Response(CR): Complete disappearance of all detectable disease * Complete Response Unconfirmed(CRu): CR, but indeterminate bone marrow * Partial Response(PR): \>50% decrease in six largest nodes/nodal masses * Stable Disease(SD): Less than PR, but not progressive disease * Relapsed Disease: In CR/CRu Patients, new lesions seen or increased by \>=50% in previous sites * Progressive Disease(PD): \>=50% increase from low in PR/Non-Responders
Up to 24 months
Secondary Outcomes (4)
Duration of Response
Up to 24 months
Time-to-Progression
Up to 24 months
Progression-Free Survival
Up to 24 months
Safety
Up to 24 months
Study Arms (1)
Lenalidomide
EXPERIMENTALOpen-label, oral lenalidomide monotherapy
Interventions
Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (45)
Tower Cancer Research Foundation
Beverly Hills, California, 90211-1850, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
The Canberra Hospital Building 3, L 2
Garran, Australian Capital Territory, 2605, Australia
Cancer Therapy Centre
Liverpool, New South Wales, 2170, Australia
Clinical Research Unit Cairns Base Hospital
Cairns, Queensland, 4870, Australia
The Townsville Hospital
Douglas, Queensland, 4814, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029, Australia
Ashford Cancer Centre
Ashford, South Australia, 5035, Australia
Royal Adelaide Hospital L3 East Wing
North Terrace, South Australia, 5000, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Box Hill Hospital, 4th Floor, Clive Ward Centre
Box Hill, Victoria, 3128, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002, Australia
St Vincents Hospital
Fitzroy, Victoria, 3065, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Institute Jules Bordet
Brussels, 1000, Belgium
Cliniques Universitaires St Luc
Brussels, 1200, Belgium
KUL
Leuven, 3000, Belgium
Clinique St Pierre
Ottignies, 1340, Belgium
Cliniques universitaires UCL de Mont-Godinne
Yvoir, 5530, Belgium
CHU Hôtel Dieu
Nantes, Cedex 01, 44093, France
Hôpital Bretonneau
Tours, Cédex 1, 37044, France
CHU Hôpital Hôtel Dieu
Angers, Cédex 9, 49033, France
Hôpital Claude Huriez
Place de Verdun Cedex, Lille, 59037, France
Hôpital Lapeyronie
Cedex, Montpellier, 34295, France
Centre Hospitalier Lyon Sud
Lyon Sud, Pierre-Bénite, 69495, France
CHRU Hôpitaux de Brabois - Hématologie
Vandœuvre-lès-Nancy, Rue Morvan Cedex, 54511, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33000, France
Hôtel Dieu Pavillon Villemur Pasteur
Clermont-Ferrand, 63000, France
Hopital Henri Mondor
Créteil, 94010, France
CHU de Dijon
Dijon, 21000, France
Hopital Michallon
Grenoble, 38043, France
CHD Les Oudairies
La Roche-sur-Yon, 85000, France
CHU Dupuytren
Limoges, 87042, France
Hôpital N.D.de Bon Secours
Metz, 57000, France
Hôpital Saint-Louis
Paris, 75010, France
Hôpital Necker
Paris, 75015, France
Hôpital de la Pitié Salpétriere
Paris, 75651, France
CHU Rennes Hôpital Pontchaillou
Rennes, 35033, France
Centre Henri Becquerel
Rouen, 76038, France
Centre René Huguenin
Saint-Cloud, 92210, France
Hôpital Purpan
Toulouse, 31059, France
Centre Hospitalier
Valence, 26953, France
Related Publications (1)
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.
PMID: 23731832RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Associate Director, Clinical Trial Disclosure
- Organization
- Celgene
Study Officials
- STUDY DIRECTOR
Kenichi Takeshita, MD
Celgene Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2008
First Posted
April 10, 2008
Study Start
March 1, 2008
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
November 25, 2019
Results First Posted
January 5, 2012
Record last verified: 2019-11