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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
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
Secondary ID [1] 0 0
NHL-13 (ML18223)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma (DLBCL) 0 0
Follicular NHL Grade 3b 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 - Rituximab

Active comparator: A - Treatment

No intervention: B - Observation


Treatment: Drugs: Rituximab
Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
event free survival
Timepoint [1] 0 0
4 years
Secondary outcome [1] 0 0
progression free survival, overall survival and safety
Timepoint [1] 0 0
four years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Transformed lymphoma
* Secondary malignancy
* Evidence of CNS - involvement
* Significant cardiac disease
* Creatinine > 2.0 mg/dl
* HIV, Hepatitis positive

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 3
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
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
683
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Gosford Hospital - Gosford
Recruitment hospital [4] 0 0
Greenslopes Hospital - Greenslopes
Recruitment hospital [5] 0 0
Prince of Wales Hospital - Sidney
Recruitment postcode(s) [1] 0 0
- Wodonga
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Gosford
Recruitment postcode(s) [4] 0 0
- Greenslopes
Recruitment postcode(s) [5] 0 0
- Sidney
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Burgenland
Country [2] 0 0
Austria
State/province [2] 0 0
Niederoesterreich
Country [3] 0 0
Austria
State/province [3] 0 0
Oberoesterreich
Country [4] 0 0
Austria
State/province [4] 0 0
Oberösterreich
Country [5] 0 0
Austria
State/province [5] 0 0
Steiermark
Country [6] 0 0
Austria
State/province [6] 0 0
Tirol
Country [7] 0 0
Austria
State/province [7] 0 0
Vorarlberg
Country [8] 0 0
Austria
State/province [8] 0 0
Bregenz
Country [9] 0 0
Austria
State/province [9] 0 0
Dornbirn
Country [10] 0 0
Austria
State/province [10] 0 0
Fuerstenfeld
Country [11] 0 0
Austria
State/province [11] 0 0
Graz
Country [12] 0 0
Austria
State/province [12] 0 0
Hohenems
Country [13] 0 0
Austria
State/province [13] 0 0
Innsbruck
Country [14] 0 0
Austria
State/province [14] 0 0
Klagenfurt
Country [15] 0 0
Austria
State/province [15] 0 0
Leoben
Country [16] 0 0
Austria
State/province [16] 0 0
Linz
Country [17] 0 0
Austria
State/province [17] 0 0
Mistelbach
Country [18] 0 0
Austria
State/province [18] 0 0
Salzburg
Country [19] 0 0
Austria
State/province [19] 0 0
Vienna
Country [20] 0 0
Austria
State/province [20] 0 0
Villach
Country [21] 0 0
Austria
State/province [21] 0 0
Voecklabruck
Country [22] 0 0
Austria
State/province [22] 0 0
Waidhofen
Country [23] 0 0
Austria
State/province [23] 0 0
Zams
Country [24] 0 0
Bosnia and Herzegovina
State/province [24] 0 0
Sarajevo
Country [25] 0 0
Bosnia and Herzegovina
State/province [25] 0 0
Tuzla
Country [26] 0 0
Brazil
State/province [26] 0 0
Goiania
Country [27] 0 0
Brazil
State/province [27] 0 0
Salvador
Country [28] 0 0
Brazil
State/province [28] 0 0
Sao Paolo
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Plovdiv
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Sofia
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Varna
Country [32] 0 0
China
State/province [32] 0 0
Bejing
Country [33] 0 0
China
State/province [33] 0 0
Chengdu
Country [34] 0 0
China
State/province [34] 0 0
Harbin
Country [35] 0 0
China
State/province [35] 0 0
Nanjing
Country [36] 0 0
China
State/province [36] 0 0
Shanghai
Country [37] 0 0
Croatia
State/province [37] 0 0
Zagreb
Country [38] 0 0
Czech Republic
State/province [38] 0 0
Boskovice
Country [39] 0 0
Czech Republic
State/province [39] 0 0
Brno
Country [40] 0 0
Czech Republic
State/province [40] 0 0
Kralove
Country [41] 0 0
Czech Republic
State/province [41] 0 0
Novi Jicin
Country [42] 0 0
Czech Republic
State/province [42] 0 0
Olomouc
Country [43] 0 0
Czech Republic
State/province [43] 0 0
Opava
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Ostrava-Poruba
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Prague
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Praha
Country [47] 0 0
Czech Republic
State/province [47] 0 0
Usti nad Labem
Country [48] 0 0
Estonia
State/province [48] 0 0
Tallin
Country [49] 0 0
Estonia
State/province [49] 0 0
Tartu
Country [50] 0 0
Hong Kong
State/province [50] 0 0
Hong Kong
Country [51] 0 0
Israel
State/province [51] 0 0
Beer Sheva
Country [52] 0 0
Israel
State/province [52] 0 0
Haifa
Country [53] 0 0
Israel
State/province [53] 0 0
Petah-Tikva
Country [54] 0 0
Israel
State/province [54] 0 0
Rehovot
Country [55] 0 0
Latvia
State/province [55] 0 0
Riga
Country [56] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [56] 0 0
Skopje
Country [57] 0 0
Malaysia
State/province [57] 0 0
Ampang
Country [58] 0 0
Malaysia
State/province [58] 0 0
Kuala Lumpur
Country [59] 0 0
Mexico
State/province [59] 0 0
Leon
Country [60] 0 0
Mexico
State/province [60] 0 0
Mexico City
Country [61] 0 0
Mexico
State/province [61] 0 0
Monterrey
Country [62] 0 0
Mexico
State/province [62] 0 0
Puebla
Country [63] 0 0
Peru
State/province [63] 0 0
Arequipa
Country [64] 0 0
Peru
State/province [64] 0 0
Callao
Country [65] 0 0
Romania
State/province [65] 0 0
Bucharest
Country [66] 0 0
Romania
State/province [66] 0 0
Targu Mures
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Belgorod
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Moscow
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Novgorod
Country [70] 0 0
Russian Federation
State/province [70] 0 0
St. Petersburg
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Ufa
Country [72] 0 0
Serbia
State/province [72] 0 0
Belgrade
Country [73] 0 0
Serbia
State/province [73] 0 0
NIs
Country [74] 0 0
Serbia
State/province [74] 0 0
Novisad
Country [75] 0 0
Serbia
State/province [75] 0 0
Sremska Kamenica
Country [76] 0 0
Slovakia
State/province [76] 0 0
Bratislava
Country [77] 0 0
Slovakia
State/province [77] 0 0
Kosice
Country [78] 0 0
Slovakia
State/province [78] 0 0
Martin
Country [79] 0 0
Slovenia
State/province [79] 0 0
Ljubljana
Country [80] 0 0
South Africa
State/province [80] 0 0
Pietremarizburg
Country [81] 0 0
South Africa
State/province [81] 0 0
Pretoria
Country [82] 0 0
Sweden
State/province [82] 0 0
Falun
Country [83] 0 0
Sweden
State/province [83] 0 0
Lulea
Country [84] 0 0
Sweden
State/province [84] 0 0
Sundsvall
Country [85] 0 0
Sweden
State/province [85] 0 0
Uddevalla
Country [86] 0 0
Taiwan
State/province [86] 0 0
Kaohsiung
Country [87] 0 0
Taiwan
State/province [87] 0 0
Taipei
Country [88] 0 0
Thailand
State/province [88] 0 0
Bangkok
Country [89] 0 0
Thailand
State/province [89] 0 0
Chiang Mai
Country [90] 0 0
Thailand
State/province [90] 0 0
Khon kaen
Country [91] 0 0
Thailand
State/province [91] 0 0
Songkla
Country [92] 0 0
Turkey
State/province [92] 0 0
Ankara
Country [93] 0 0
Turkey
State/province [93] 0 0
Eskisehir
Country [94] 0 0
Turkey
State/province [94] 0 0
Gaziantep
Country [95] 0 0
Turkey
State/province [95] 0 0
Kayseri

Funding & Sponsors
Primary sponsor type
Other
Name
Arbeitsgemeinschaft medikamentoese Tumortherapie
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Hoffmann-La Roche
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00400478
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.
Public notes

Contacts
Principal investigator
Name 0 0
Ulrich Jaeger, Prof. Dr.
Address 0 0
Medical University of Vienna
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/NCT00400478