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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00474188
Registration number
NCT00474188
Ethics application status
Date submitted
14/05/2007
Date registered
16/05/2007
Date last updated
2/09/2009
Titles & IDs
Public title
A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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Scientific title
A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Lenalidomide (Revlimid ®) in Combination With Dexamethasone in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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Secondary ID [1]
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CC-5013-NHL-005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-cell 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 - CC-5013 (lenalidomide)
Treatment: Drugs - dexamethasone
Experimental: Single Arm -
Treatment: Drugs: CC-5013 (lenalidomide)
Lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle administerd in combination with dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle
Treatment: Drugs: dexamethasone
Dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle administered in combination with lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 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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Tumor Response Rate
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Assessment method [1]
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Number of participants demonstrating complete or partial tumor response (Cheson B, Horning S, Coiffier B, Shipp M, Fisher R, Connors J, et al, Report of an international workshop to standardize response criteria for non-Hodgkins' lymphoma. J Clin Oncol.1999;17:1244-53).
Study terminated prematurely. Analysis not conducted.
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Timepoint [1]
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One Year
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Secondary outcome [1]
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Tumor Control Rate
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Assessment method [1]
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Number of participants demonstrating complete tumor response, partial tumor response, or stable disease.
Study terminated prematurely. Analysis not conducted.
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Timepoint [1]
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One Year
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Secondary outcome [2]
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Duration of Response
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Assessment method [2]
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Time from first demonstration of at least a partial response to the first documentation of disease progression, including death due to non-Hodgkin's lymphoma.
Study terminated prematurely. Analysis not conducted.
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Timepoint [2]
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One year
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Secondary outcome [3]
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Time to Progression
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Assessment method [3]
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Time from the start of study drug therapy to the first documentation of disease progression.
Study terminated prematurely. Analysis not conducted.
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Timepoint [3]
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One year
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Secondary outcome [4]
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Progression-free Survival
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Assessment method [4]
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Time from the start of study drug therapy to the first observation of disease progression or death due to any cause.
Study terminated prematurely. Analysis not conducted.
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Timepoint [4]
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One year
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Eligibility
Key inclusion criteria
* Biopsy-proven diffuse large B-cell non-Hodgkin's lymphoma
* Relapsed or refractory to previous therapy for non-Hodgkin's lymphoma
* Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
* ECOG performance score of 0,1 or 2
* Willing to follow the pregnancy precautions
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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
* Any of the following laboratory abnormalities.
* Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
* Platelet count < 60,000/mm3 (60 x 109/L).
* Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
* Serum total bilirubin > 2.0 mg/dL (34 µmol/L).
* Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
* History of active CNS lymphoma within the previous 3 months
* Subjects not willing or unable to take DVT prophylaxis
* History of other malignancies within the past year
* Positive HIV or active Hepatitis B or C
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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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
Stopped early
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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
1/05/2007
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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
1/12/2008
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Sample size
Target
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Accrual to date
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Final
26
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred Hospital - Melbourne
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Recruitment hospital [2]
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Frankston Hospital - Frankston
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Recruitment hospital [3]
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HOCA - South Brisbane
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Recruitment hospital [4]
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Border Medical Oncology - Wodonga
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Recruitment postcode(s) [1]
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VIC3050 - Melbourne
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Recruitment postcode(s) [2]
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VIC 3199 - Frankston
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Recruitment postcode(s) [3]
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QLD 4101 - South Brisbane
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Recruitment postcode(s) [4]
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VIC 3690 - Wodonga
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Recruitment outside Australia
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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Florida
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United States of America
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Georgia
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Illinois
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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Michigan
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New Jersey
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North Carolina
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Ohio
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Texas
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United States of America
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State/province [14]
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Utah
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Country [15]
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Canada
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State/province [15]
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Alberta
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Celgene Corporation
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.
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Trial website
https://clinicaltrials.gov/study/NCT00474188
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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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Andrew Spencer, MD
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Address
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The Alfred
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00474188
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