Back to resultsA Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma (EXPECT)
Primary Purpose
T-cell Non-Hodgkin's Lymphoma
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lenalidomide
Sponsored by
About this trial
This is an interventional treatment trial for T-cell Non-Hodgkin's Lymphoma focused on measuring NHL, Non-Hodgkin's Lymphoma, T-cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- Cutaneous T-cell Lymphoma of subtype Sézary Syndrome.
Sites / Locations
- Tower Cancer Research Foundation
- Cancer Center of Kansas
- Hackensack University Medical Center
- Western Pennsylvania Hospital
- The Canberra Hospital Building 3, L 2
- Cancer Therapy Centre
- Clinical Research Unit Cairns Base Hospital
- The Townsville Hospital
- Royal Brisbane & Women's Hospital
- Ashford Cancer Centre
- Royal Adelaide Hospital L3 East Wing
- Royal Hobart Hospital
- Box Hill Hospital, 4th Floor, Clive Ward Centre
- Monash Medical Centre
- Peter MacCallum Cancer Centre
- St Vincents Hospital
- Sir Charles Gairdner Hospital
- Institute Jules Bordet
- Cliniques Universitaires St Luc
- KUL
- Clinique St Pierre
- Cliniques universitaires UCL de Mont-Godinne
- CHU Hôtel Dieu
- Hôpital Bretonneau
- CHU Hôpital Hôtel Dieu
- Hôpital Claude Huriez
- Hôpital Lapeyronie
- Centre Hospitalier Lyon Sud
- CHRU Hôpitaux de Brabois - Hématologie
- Polyclinique Bordeaux Nord Aquitaine
- Hôtel Dieu Pavillon Villemur Pasteur
- Hopital Henri Mondor
- CHU de Dijon
- Hopital Michallon
- CHD Les Oudairies
- CHU Dupuytren
- Hôpital N.D.de Bon Secours
- Hôpital Saint-Louis
- Hôpital Necker
- Hôpital de la Pitié Salpétriere
- CHU Rennes Hôpital Pontchaillou
- Centre Henri Becquerel
- Centre René Huguenin
- Hôpital Purpan
- Centre Hospitalier
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lenalidomide
Arm Description
Open-label, oral lenalidomide monotherapy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Duration of Response
Kaplan-Meier Estimate of duration of response calculated as the time from first computed tomography (CT) Scan or magnetic resonance imaging (MRI) that demonstrates at least a partial response to the first documentation of disease progression, including death due to Non-Hodgkin's Lymphoma.
Time-to-Progression
Kaplan-Meier estimate of time-to-progression is calculated as the time from the start of study drug therapy to the first documentation of progressive disease.
Progression-Free Survival
Kaplan-Meier estimate of progression-free survival is defined as the start of study drug therapy to the first observation of disease progression or death due to any cause.
Safety
Summary of Treatment-Emergent Events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3: Following is the scale: Grade 1=Mild Adverse Event (AE), Grade 2=Moderate AE, Grade 3=Severe and Undesirable AE, Grade 4=Life-threatening or Disabling AE, and Grade 5=Death Related to AE.)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00655668
Brief Title
A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
Acronym
EXPECT
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Decision not to pursue as single agent in the study population.
Study Start Date
March 1, 2008 (Actual)
Primary Completion Date
March 1, 2010 (Actual)
Study Completion Date
April 1, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T-cell Non-Hodgkin's Lymphoma
Keywords
NHL, Non-Hodgkin's Lymphoma, T-cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lenalidomide
Arm Type
Experimental
Arm Description
Open-label, oral lenalidomide monotherapy
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle
Primary Outcome Measure Information:
Title
Participants Categorized by Best Response as Determined by Investigator
Description
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
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Duration of Response
Description
Kaplan-Meier Estimate of duration of response calculated as the time from first computed tomography (CT) Scan or magnetic resonance imaging (MRI) that demonstrates at least a partial response to the first documentation of disease progression, including death due to Non-Hodgkin's Lymphoma.
Time Frame
Up to 24 months
Title
Time-to-Progression
Description
Kaplan-Meier estimate of time-to-progression is calculated as the time from the start of study drug therapy to the first documentation of progressive disease.
Time Frame
Up to 24 months
Title
Progression-Free Survival
Description
Kaplan-Meier estimate of progression-free survival is defined as the start of study drug therapy to the first observation of disease progression or death due to any cause.
Time Frame
Up to 24 months
Title
Safety
Description
Summary of Treatment-Emergent Events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3: Following is the scale: Grade 1=Mild Adverse Event (AE), Grade 2=Moderate AE, Grade 3=Severe and Undesirable AE, Grade 4=Life-threatening or Disabling AE, and Grade 5=Death Related to AE.)
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
Cutaneous T-cell Lymphoma of subtype Sézary Syndrome.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenichi Takeshita, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Tower Cancer Research Foundation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211-1850
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
The Canberra Hospital Building 3, L 2
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Cancer Therapy Centre
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Clinical Research Unit Cairns Base Hospital
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
The Townsville Hospital
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Ashford Cancer Centre
City
Ashford
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Royal Adelaide Hospital L3 East Wing
City
North Terrace
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Box Hill Hospital, 4th Floor, Clive Ward Centre
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
St Vincents Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Institute Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Cliniques Universitaires St Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
KUL
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Clinique St Pierre
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Cliniques universitaires UCL de Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
CHU Hôtel Dieu
City
Nantes
State/Province
Cedex 01
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Bretonneau
City
Tours
State/Province
Cédex 1
ZIP/Postal Code
37044
Country
France
Facility Name
CHU Hôpital Hôtel Dieu
City
Angers
State/Province
Cédex 9
ZIP/Postal Code
49033
Country
France
Facility Name
Hôpital Claude Huriez
City
Place De Verdun Cedex
State/Province
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Lapeyronie
City
Cedex
State/Province
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Lyon Sud
State/Province
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
CHRU Hôpitaux de Brabois - Hématologie
City
Vandoeuvre Les Nancy
State/Province
Rue Morvan Cedex
ZIP/Postal Code
54511
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hôtel Dieu Pavillon Villemur Pasteur
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Hopital Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHD Les Oudairies
City
La Roche Sur Yon
ZIP/Postal Code
85000
Country
France
Facility Name
CHU Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hôpital N.D.de Bon Secours
City
Metz
ZIP/Postal Code
57000
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital de la Pitié Salpétriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CHU Rennes Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre René Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Hospitalier
City
Valence
ZIP/Postal Code
26953
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
23731832
Citation
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.
Results Reference
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Learn more about this trial
A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
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