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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/NCT01197560
Registration number
NCT01197560
Ethics application status
Date submitted
29/07/2010
Date registered
9/09/2010
Date last updated
25/11/2019
Titles & IDs
Public title
Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
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Scientific title
A Phase 2/3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Lenalidomide (Revlimid ®) Versus Investigator's Choice in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
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Secondary ID [1]
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CC-5013-DLC-001
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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 - Lenalidomide
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Rituximab
Treatment: Drugs - Etoposide
Experimental: Lenalidomide - Lenalidomide 25 mg capsules by mouth on days 1-21 of each 28 day cycle. For patients with Creatinine Clearance = 30 mL/min but < 60 mL/min, lenalidomide 10 mg (max escalation is 15 mg).
Active Comparator: Investigators Choice - One of the following:
Gemcitabine, Oxaliplatin, Rituximab, or Etoposide
Treatment: Drugs: Lenalidomide
Lenalidomide 25 mg orally for 21/28 days until Diffuse Large B-Cell Lymphoma (DLBCL) progressive disease. For patients with Creatinine Clearance = 30 mL/min but < 60 mL/min, lenalidomide 10 mg (max escalation is 15 mg).
Treatment: Drugs: Gemcitabine
Suggested starting doses and regimens for Gemcitabine is 1,250 mg/m^2 intravenous (IV) administration on days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 every 28 days for 6 Cycles
Treatment: Drugs: Oxaliplatin
Suggested starting dose and regimen for Oxaliplatin is 100 mg/m^2 IV day 1 for 21 days for 6 Cycles
Treatment: Drugs: Rituximab
Suggested starting dose for Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
Treatment: Drugs: Etoposide
Suggested starting doses for Etoposide are:
100 mg/m^2 IV days 1-5 every 28 days for 6 Cycles, or 100 mg/m^2 IV days 1-3 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-21 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-14 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-10 every 28 days for 6 Cycles
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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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Stage 1: Percentage of Participants With an Overall Response According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999 and Evaluated by the Independent Response Adjudication Committee (IRAC)
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Assessment method [1]
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An overall response is a complete response (CR), unconfirmed complete response (CRu) or partial response (PR) and was evaluated by the IRAC. A CR = complete disappearance of disease and related symptoms. Lymph nodes and nodal masses regressed on computed tomography to normal size (= 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy and = 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and > 1.0 cm in their short axis prior to therapy). Spleen and/or liver not palpable on exam, normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, infiltrate must have cleared on repeat biopsy. PR = = 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in other nodes, liver, or spleen. Splenic and hepatic nodules regressed by = 50% in their SPD or for single nodules, in the greatest transverse diameter;no new disease.
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Timepoint [1]
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From the date of randomization to the data cut-off of 4 July 2013; when all patients reached the scheduled 16-week assessment or had progressed/died before the scheduled 16-week assessment); the median study duration was 27.0 and 19.7 weeks, respectively.
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Primary outcome [2]
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Stage 1: Percentage of Participants With an Overall Response According to the IWG Response Criteria Based on the Investigators Assessment at the Final Data Cut During the Core Treatment Phase
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Assessment method [2]
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Response was defined as having a CR, CRu or PR, based on IWG 1999 Response Criteria for NHL as evaluated by the investigators. CR = complete disappearance of disease and disease related symptoms. All lymph nodes and nodal masses regressed on computed tomography to normal size (= 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy and = 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and > 1.0 cm in their short axis prior to therapy). Spleen and/or liver not palpable on physical exam, normal size by imaging, and absence of nodules related to lymphoma. If BM was involved prior to therapy, infiltrate must have cleared on repeat biopsy. PR = = 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in the other nodes, liver, or spleen. Splenic and hepatic nodules regressed by = 50% in their SPD or, for single nodules, in the greatest transverse diameter. No new disease.
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Timepoint [2]
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From the date of randomization to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.
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Secondary outcome [1]
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Number of Participants With Treatment Emergent Events (TEAEs) in the Overall Treatment Phase by Initial Treatment Assignment
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Assessment method [1]
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A TEAE was defined as an AE that begins or worsens in intensity of frequency on or after the first dose of study drug through 28 days after last dose of study drug.
A serious adverse event (SAE) is any:
Death;
Life-threatening event;
Any inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability or incapacity;
Congenital anomaly or birth defect;
Any other important medical event The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event.The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.03) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death
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Timepoint [1]
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From first dose of study drug to the final data cut-off date of 18 May 2018; median study duration was 27.0 and 19.7 weeks, respectively.
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Secondary outcome [2]
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Stage 2: Overall Response Rate (ORR)
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Assessment method [2]
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ORR is defined as: Complete Response + Complete Response unconfirmed + Partial Response based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).
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Timepoint [2]
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Approximately 3.5 years
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Secondary outcome [3]
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Stage 2: Duration of Response (DoR)
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Assessment method [3]
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Length of time of overall response (Complete Response + Complete Response unconfirmed + Partial Response) based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).
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Timepoint [3]
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Approximately 3.5 years
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Secondary outcome [4]
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Stage 2: Overall Survival (OS)
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Assessment method [4]
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Overall survival was defined as time from randomization until death of any cause.
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Timepoint [4]
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Approximately 3.5 years
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Secondary outcome [5]
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Stage 2: Duration of Complete Response
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Assessment method [5]
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Length of time of complete response (Complete Response + Complete Response unconfirmed) based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).
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Timepoint [5]
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Approximately 3.5 years
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Secondary outcome [6]
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Stage 2: Overall Response Rate for With a Duration of Response Lasting = 16 Weeks
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Assessment method [6]
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Complete Response + Complete Response unconfirmed + Partial Response for participants with a duration of response lasting = 16 weeks based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).
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Timepoint [6]
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Approximately 3.5 years
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Secondary outcome [7]
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Stage 2: Time to Progression
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Assessment method [7]
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Length of time until disease progression occurs
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Timepoint [7]
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Approximately 3.5 years
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Secondary outcome [8]
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Stage 2: Health Related Quality of Life Questionnaires
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Assessment method [8]
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Quality of Life based on the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EQ-5D assessments
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Timepoint [8]
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Approximately 3.5 years
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Eligibility
Key inclusion criteria
- Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL).
- Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab
and an anthracycline, and one additional combination chemotherapy or stem cell
transplant.
- Measurable DLBCL disease by computed tomograph (CT) / magnetic resonance imagining
(MRI).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
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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
- Diagnosis of lymphoma histologies other than DLBCL.
- History of malignancies, other than DLBCL, unless the patient has been disease free
for 3 years or more.
- Eligible for autologous stem cell transplant.
- Known seropositive for, or history of, active human immunodeficiency virus (HIV)
hepatitis B virus (HBV), hepatitis C virus (HCV)
- Neuropathy grade 4.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
2/09/2010
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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
5/04/2018
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Sample size
Target
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Accrual to date
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Final
111
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Royal Brisbaine and Womens Hospital - Herston
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Recruitment hospital [3]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment outside Australia
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California
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Florida
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Austria
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Innsbruck
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Hradec Kralove 5
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Praha
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Barcelona
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Umea
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Sweden
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Uppsala
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Bournemouth
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Exeter
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Leeds
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London
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Manchester
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Southhampton
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Celgene
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to compare lenalidomide to a control drug and see which one
delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01197560
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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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Adrian Kilcoyne, 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/NCT01197560
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