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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00655668
Registration number
NCT00655668
Ethics application status
Date submitted
4/04/2008
Date registered
10/04/2008
Date last updated
25/11/2019
Titles & IDs
Public title
A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
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Scientific 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
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Secondary ID [1]
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2007-002171-13
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Secondary ID [2]
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CC-5013-TCL-001
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Universal Trial Number (UTN)
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Trial acronym
EXPECT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
T-cell Non-Hodgkin's Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Lenalidomide
Experimental: Lenalidomide - Open-label, oral lenalidomide monotherapy
Treatment: Drugs: Lenalidomide
Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Participants Categorized by Best Response as Determined by Investigator
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Assessment method [1]
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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
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Timepoint [1]
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Up to 24 months
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Secondary outcome [1]
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Duration of Response
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 24 months
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Secondary outcome [2]
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Time-to-Progression
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 24 months
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Secondary outcome [3]
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Progression-Free Survival
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 24 months
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Secondary outcome [4]
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Safety
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Assessment method [4]
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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.)
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Timepoint [4]
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Up to 24 months
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Cutaneous T-cell Lymphoma of subtype Sézary Syndrome.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2010
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Sample size
Target
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Accrual to date
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Final
54
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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The Canberra Hospital Building 3, L 2 - Garran
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Cancer Therapy Centre - Liverpool
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Clinical Research Unit Cairns Base Hospital - Cairns
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The Townsville Hospital - Douglas
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Royal Brisbane & Women's Hospital - Herston
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Ashford Cancer Centre - Ashford
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Royal Adelaide Hospital L3 East Wing - North Terrace
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Royal Hobart Hospital - Hobart
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Box Hill Hospital, 4th Floor, Clive Ward Centre - Box Hill
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Monash Medical Centre - Clayton
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Peter MacCallum Cancer Centre - East Melbourne
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St Vincents Hospital - Fitzroy
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2170 - Liverpool
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4870 - Cairns
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4814 - Douglas
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4029 - Herston
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5035 - Ashford
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5000 - North Terrace
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7000 - Hobart
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Recruitment postcode(s) [9]
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3128 - Box Hill
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3168 - Clayton
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Recruitment postcode(s) [11]
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3002 - East Melbourne
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Recruitment postcode(s) [12]
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3065 - Fitzroy
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Recruitment postcode(s) [13]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Kansas
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New Jersey
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Belgium
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Bruxelles
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Belgium
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Leuven
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Belgium
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Belgium
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Yvoir
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France
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Lille
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Montpellier
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Pierre-Bénite
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France
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Rue Morvan Cedex
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Bordeaux
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Grenoble
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La Roche Sur Yon
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France
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Limoges
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France
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Metz
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Paris
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Rennes
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Rouen
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Saint Cloud
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Toulouse
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Celgene
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00655668
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kenichi Takeshita, MD
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Address
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Celgene Corporation
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00655668
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