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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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
Secondary ID [1] 0 0
CC-5013-DLC-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
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.
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
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.
Secondary outcome [1] 0 0
Number of Participants With Treatment Emergent Events (TEAEs) in the Overall Treatment Phase by Initial Treatment Assignment
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Stage 2: Overall Response Rate (ORR)
Timepoint [2] 0 0
Approximately 3.5 years
Secondary outcome [3] 0 0
Stage 2: Duration of Response (DoR)
Timepoint [3] 0 0
Approximately 3.5 years
Secondary outcome [4] 0 0
Stage 2: Overall Survival (OS)
Timepoint [4] 0 0
Approximately 3.5 years
Secondary outcome [5] 0 0
Stage 2: Duration of Complete Response
Timepoint [5] 0 0
Approximately 3.5 years
Secondary outcome [6] 0 0
Stage 2: Overall Response Rate for With a Duration of Response Lasting = 16 Weeks
Timepoint [6] 0 0
Approximately 3.5 years
Secondary outcome [7] 0 0
Stage 2: Time to Progression
Timepoint [7] 0 0
Approximately 3.5 years
Secondary outcome [8] 0 0
Stage 2: Health Related Quality of Life Questionnaires
Timepoint [8] 0 0
Approximately 3.5 years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/04/2018
Sample size
Target
Accrual to date
Final
111
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Brisbaine and Womens Hospital - Herston
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Florida
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United States of America
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Georgia
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United States of America
State/province [4] 0 0
Illinois
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United States of America
State/province [5] 0 0
Maryland
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United States of America
State/province [6] 0 0
Michigan
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United States of America
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Mississippi
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United States of America
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Missouri
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United States of America
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New York
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United States of America
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South Dakota
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United States of America
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Tennessee
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United States of America
State/province [12] 0 0
Texas
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Austria
State/province [13] 0 0
Innsbruck
Country [14] 0 0
Austria
State/province [14] 0 0
Salzburg
Country [15] 0 0
Austria
State/province [15] 0 0
Vienna
Country [16] 0 0
Czechia
State/province [16] 0 0
Hradec Kralove 5
Country [17] 0 0
Czechia
State/province [17] 0 0
Praha
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France
State/province [18] 0 0
Brest Cedex 2
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France
State/province [19] 0 0
Grenoble
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France
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La Roche Sur Yon
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France
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Lyon
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France
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Marsielle
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France
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Nantes Cedex 1
Country [24] 0 0
France
State/province [24] 0 0
Perpignan
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France
State/province [25] 0 0
Pessac
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France
State/province [26] 0 0
Rennes
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France
State/province [27] 0 0
Toulouse
Country [28] 0 0
France
State/province [28] 0 0
Vandoeuvre-les Nancy cedex
Country [29] 0 0
Italy
State/province [29] 0 0
Bologna
Country [30] 0 0
Italy
State/province [30] 0 0
Firenze
Country [31] 0 0
Italy
State/province [31] 0 0
Genova
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Italy
State/province [32] 0 0
Miano
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Italy
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Napoli
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Italy
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Pavia
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Italy
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Rionero In Vulture (PZ)
Country [36] 0 0
Italy
State/province [36] 0 0
Roma
Country [37] 0 0
Italy
State/province [37] 0 0
Terni
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Spain
State/province [38] 0 0
Barcelona
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Spain
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Cordoba
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Spain
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Marbella
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Spain
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Ourense
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Spain
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Pamplona
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Spain
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Salamanca
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Sweden
State/province [44] 0 0
Umea
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Sweden
State/province [45] 0 0
Uppsala
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United Kingdom
State/province [46] 0 0
Bournemouth
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United Kingdom
State/province [47] 0 0
Exeter
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Leeds
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United Kingdom
State/province [49] 0 0
London
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United Kingdom
State/province [50] 0 0
Manchester
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Plymouth
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Southhampton
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01197560
Trial related presentations / publications
Czuczman MS, Trneny M, Davies A, Rule S, Linton KM, Wagner-Johnston N, Gascoyne RD, Slack GW, Brousset P, Eberhard DA, Hernandez-Ilizaliturri FJ, Salles G, Witzig TE, Zinzani PL, Wright GW, Staudt LM, Yang Y, Williams PM, Lih CJ, Russo J, Thakurta A, Hagner P, Fustier P, Song D, Lewis ID. A Phase 2/3 Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Lenalidomide Versus Investigator's Choice in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma. Clin Cancer Res. 2017 Aug 1;23(15):4127-4137. doi: 10.1158/1078-0432.CCR-16-2818. Epub 2017 Apr 5.
Hernandez-Ilizaliturri FJ, Deeb G, Zinzani PL, Pileri SA, Malik F, Macon WR, Goy A, Witzig TE, Czuczman MS. Higher response to lenalidomide in relapsed/refractory diffuse large B-cell lymphoma in nongerminal center B-cell-like than in germinal center B-cell-like phenotype. Cancer. 2011 Nov 15;117(22):5058-66. doi: 10.1002/cncr.26135. Epub 2011 Apr 14.
Public notes

Contacts
Principal investigator
Name 0 0
Adrian Kilcoyne, MD
Address 0 0
Celgene Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01197560