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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/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/ct2/show/NCT00400478
Trial related presentations / publications
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