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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00400478
Registration number
NCT00400478
Ethics application status
Date submitted
16/11/2006
Date registered
17/11/2006
Date last updated
26/05/2016
Titles & IDs
Public title
A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13
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Scientific title
A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-cell Lymphoma: NHL-13
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Secondary ID [1]
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NHL-13 (ML18223)
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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 (DLBCL)
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Follicular NHL Grade 3b
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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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0
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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 - Rituximab
Active comparator: A - Treatment
No intervention: B - Observation
Treatment: Drugs: Rituximab
Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)
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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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event free survival
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Assessment method [1]
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Timepoint [1]
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4 years
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Secondary outcome [1]
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progression free survival, overall survival and safety
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Assessment method [1]
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Timepoint [1]
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four years
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Eligibility
Key inclusion criteria
* 4 to 8 cycles R-CHOP/like, total of 8x Rituximab
* CR, CRu
* ECOG/ 0.1 or 2
* Known IPI at time of diagnosis
* Age > 18 years
* Negative pregnancy test
* Men must agree not to father a child during the therapy
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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
* Transformed lymphoma
* Secondary malignancy
* Evidence of CNS - involvement
* Significant cardiac disease
* Creatinine > 2.0 mg/dl
* HIV, Hepatitis positive
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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 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
1/01/2006
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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
1/03/2013
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Sample size
Target
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Accrual to date
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Final
683
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Border Medical Oncology - Wodonga
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Recruitment hospital [2]
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Concord Repatriation General Hospital - Concord
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Gosford Hospital - Gosford
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Recruitment hospital [4]
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Greenslopes Hospital - Greenslopes
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Recruitment hospital [5]
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Prince of Wales Hospital - Sidney
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Recruitment postcode(s) [1]
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- Wodonga
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Recruitment postcode(s) [2]
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- Concord
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Recruitment postcode(s) [3]
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- Gosford
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Recruitment postcode(s) [4]
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- Greenslopes
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Recruitment postcode(s) [5]
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- Sidney
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Recruitment outside Australia
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Austria
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Burgenland
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Austria
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Niederoesterreich
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Tirol
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Graz
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Hohenems
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Klagenfurt
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Leoben
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Linz
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Gaziantep
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Kayseri
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Funding & Sponsors
Primary sponsor type
Other
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Name
Arbeitsgemeinschaft medikamentoese Tumortherapie
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Commercial sector/industry
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Hoffmann-La Roche
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Ethics approval
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Summary
Brief summary
This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL. Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.
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Trial website
https://clinicaltrials.gov/study/NCT00400478
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Trial related presentations / publications
Jaeger U, Trneny M, Melzer H, Praxmarer M, Nawarawong W, Ben Yehuda D, Goldstein D, Mihaljevic B, Ilhan O, Ballova V, Hedenus M, Hsiao LT, Au WY, Burgstaller S, Weidinger G, Keil F, Dittrich C, Skrabs C, Klingler A, Chott A, Fridrik MA, Greil R; AGMT-NHL13 Investigators. Rituximab maintenance for patients with aggressive B-cell lymphoma in first remission: results of the randomized NHL13 trial. Haematologica. 2015 Jul;100(7):955-63. doi: 10.3324/haematol.2015.125344. Epub 2015 Apr 24. Jaeger U, Praxmarer M, Greil R; AGMT-NHL13 investigators. Response to comment by P. Vassilakopoulos and colleagues. Haematologica. 2015 Nov;100(11):e482. doi: 10.3324/haematol.2015.134288. No abstract available.
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Public notes
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Contacts
Principal investigator
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Ulrich Jaeger, Prof. Dr.
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Address
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Medical University of Vienna
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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
Type
Citations or Other Details
Journal
Jaeger U, Trneny M, Melzer H, Praxmarer M, Nawaraw...
[
More Details
]
Journal
Jaeger U, Praxmarer M, Greil R; AGMT-NHL13 investi...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00400478
Download to PDF