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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/NCT01724021




Registration number
NCT01724021
Ethics application status
Date submitted
5/11/2012
Date registered
9/11/2012
Date last updated
23/01/2018

Titles & IDs
Public title
A Study of Participant Preference With Subcutaneous Versus Intravenous MabThera/Rituxan in Participants With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a
Scientific title
A Randomized, Open-label, Mutli-centre Study to Evaluate Patient Preference With Subcutaneous Administration of Rituximab Versus Intravenous Rituximab in Previously Untreated Patients With CD20+ Diffuse Large B-cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2, OR 3A
Secondary ID [1] 0 0
2012-003230-17
Secondary ID [2] 0 0
MO28457
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma, Non-Hodgkin's 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 - Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Treatment: Drugs - Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Treatment: Drugs - Bendamustine
Treatment: Drugs - Rituximab
Treatment: Drugs - Rituximab
Treatment: Drugs - Rituximab
Treatment: Drugs - Rituximab

Experimental: Arm A - Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.

Experimental: Arm B - Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.


Treatment: Drugs: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)
Standard chemotherapy

Treatment: Drugs: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)
Standard chemotherapy

Treatment: Drugs: Bendamustine
Standard chemotherapy

Treatment: Drugs: Rituximab
1400 mg subcutaneously (SC), Day 1 Cycles 2-4

Treatment: Drugs: Rituximab
375 mg/m2 IV, Day 1 Cycles 1-4

Treatment: Drugs: Rituximab
375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8

Treatment: Drugs: Rituximab
1400 mg SC, Day 1 Cycles 5-8
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
Timepoint [1] 0 0
Cycle 6 (Up to 24 weeks)
Primary outcome [2] 0 0
Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8
Timepoint [2] 0 0
Cycle 8 (Up to 32 weeks)
Secondary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events (AEs)
Timepoint [1] 0 0
Randomization of first participant to clinical cutoff date (Up to 4 years)
Secondary outcome [2] 0 0
Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])
Timepoint [2] 0 0
Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)
Secondary outcome [3] 0 0
Cancer Therapy Satisfaction Questionnaire (CTSQ) Score
Timepoint [3] 0 0
During Cycle 4, 8 of treatment (Up to 32 weeks)
Secondary outcome [4] 0 0
Rituximab Administration Satisfaction Questionnaire (RASQ) Score
Timepoint [4] 0 0
During Cycle 4, 8 of treatment (Up to 32 weeks)
Secondary outcome [5] 0 0
Complete Response (CR) Rate
Timepoint [5] 0 0
28 days (± 3 days) after Day 1 of the last dose of induction treatment
Secondary outcome [6] 0 0
Event-free Survival (EFS)
Timepoint [6] 0 0
From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Secondary outcome [7] 0 0
Disease-free Survival (DFS)
Timepoint [7] 0 0
From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Secondary outcome [8] 0 0
Progression-free Survival (PFS)
Timepoint [8] 0 0
From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Secondary outcome [9] 0 0
Overall Survival (OS)
Timepoint [9] 0 0
From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)
Secondary outcome [10] 0 0
Percentage of Participants With Anti-Rituximab Antibodies Over Time
Timepoint [10] 0 0
Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Secondary outcome [11] 0 0
Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time
Timepoint [11] 0 0
Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)
Secondary outcome [12] 0 0
Summary of Observed Serum Rituximab Concentration
Timepoint [12] 0 0
Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

Eligibility
Key inclusion criteria
- Adult participants , >/= 18 and </= 80 years of age

- Histologically confirmed, previously untreated CD20+ diffuse large B-cell lymphoma
(DLBCL) or CD20+ follicular non-Hodgkin's lymphoma (NHL) Grade 1, 2, or 3a, according
to World Health Organization (WHO) classification

- An International Prognostic Index (IPI) score of 1-4 or IPI score of 0 with bulky
disease, defined as one lesion >/= 7.5 cm, or Follicular Lymphoma International
Prognostic Index (FLIPI; low, intermediate or high risk)

- At least one bi-dimensionally measurable lesion defined as >/=1.5 cm in its largest
dimension on CT scan

- Eastern Cooperative Oncology Group (ECOG) performance status </= 3
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Transformed lymphoma or follicular lymphoma IIIB

- Primary central nervous system (CNS) lymphoma, histologic evidence of transformation
to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary
cutaneous DLBCL, or primary DLBCL of the testis

- History of other malignancy that could affect compliance with the protocol or
interpretation of the results; this includes a malignancy that has been treated but
not with curative intent, unless the malignancy has been in remission for >/= 5 years
prior to enrolment; participants with a history of curatively treated basal or
squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are
eligible

- Prior therapy for DLBCL or NHL, with the exception of nodal biopsy or local
irradiation

- Prior treatment with cytotoxic drugs (with the exclusion of intrathecal methotrexate
for CNS prophylaxis in DLBCL) or rituximab for another condition, or prior use of an
anti-CD20 drug

- Prior use of monoclonal antibody within 3 months prior to randomization

- Chemotherapy or other investigational therapy within 28 days prior to randomization

- Ongoing corticosteroid use > 30 mg/day prednisolone or equivalent

- Inadequate renal. hematologic or hepatic function

- Active and/or severe infection or any major episode of infection within 4 weeks prior
to randomization

- Active hepatitis B virus or active hepatitis C virus infection

- History of human immunodeficiency (HIV) seropositive status

- A positive pregnancy test in women of childbearing potential

- Life expectancy of less than 6 months

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
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
Accrual to date
Final
743
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Canberra
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Liverpool
Recruitment hospital [4] 0 0
- Randwick
Recruitment hospital [5] 0 0
- Brisbane
Recruitment hospital [6] 0 0
- Adelaide
Recruitment hospital [7] 0 0
- Hobart
Recruitment hospital [8] 0 0
- Geelong
Recruitment hospital [9] 0 0
- Malvern
Recruitment hospital [10] 0 0
- Melbourne
Recruitment hospital [11] 0 0
- Wodonga
Recruitment hospital [12] 0 0
- Nedlands
Recruitment hospital [13] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
4101 - Brisbane
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3220 - Geelong
Recruitment postcode(s) [9] 0 0
3144 - Malvern
Recruitment postcode(s) [10] 0 0
3084 - Melbourne
Recruitment postcode(s) [11] 0 0
3690 - Wodonga
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment postcode(s) [13] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Corrientes
Country [3] 0 0
Argentina
State/province [3] 0 0
Santa Fé
Country [4] 0 0
Austria
State/province [4] 0 0
Krems
Country [5] 0 0
Austria
State/province [5] 0 0
Linz
Country [6] 0 0
Austria
State/province [6] 0 0
Salzburg
Country [7] 0 0
Austria
State/province [7] 0 0
Steyr
Country [8] 0 0
Austria
State/province [8] 0 0
Wien
Country [9] 0 0
Brazil
State/province [9] 0 0
MG
Country [10] 0 0
Brazil
State/province [10] 0 0
PE
Country [11] 0 0
Brazil
State/province [11] 0 0
PR
Country [12] 0 0
Brazil
State/province [12] 0 0
RS
Country [13] 0 0
Brazil
State/province [13] 0 0
SP
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Chile
State/province [17] 0 0
Santiago
Country [18] 0 0
Chile
State/province [18] 0 0
Viña del Mar
Country [19] 0 0
Colombia
State/province [19] 0 0
Monteria
Country [20] 0 0
Croatia
State/province [20] 0 0
Osijek
Country [21] 0 0
Denmark
State/province [21] 0 0
Aalborg
Country [22] 0 0
Denmark
State/province [22] 0 0
Holstebro
Country [23] 0 0
Dominican Republic
State/province [23] 0 0
Santiago de los Caballeros
Country [24] 0 0
Egypt
State/province [24] 0 0
Alexandria
Country [25] 0 0
Egypt
State/province [25] 0 0
Cairo
Country [26] 0 0
El Salvador
State/province [26] 0 0
San Salvador
Country [27] 0 0
Germany
State/province [27] 0 0
Aschaffenburg
Country [28] 0 0
Germany
State/province [28] 0 0
Augsburg
Country [29] 0 0
Germany
State/province [29] 0 0
Bamberg
Country [30] 0 0
Germany
State/province [30] 0 0
Bayreuth
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Bielefeld
Country [33] 0 0
Germany
State/province [33] 0 0
Bochum
Country [34] 0 0
Germany
State/province [34] 0 0
Bonn
Country [35] 0 0
Germany
State/province [35] 0 0
Bottrop
Country [36] 0 0
Germany
State/province [36] 0 0
Brandenburg
Country [37] 0 0
Germany
State/province [37] 0 0
Bremen
Country [38] 0 0
Germany
State/province [38] 0 0
Bremerhaven
Country [39] 0 0
Germany
State/province [39] 0 0
Coesfeld
Country [40] 0 0
Germany
State/province [40] 0 0
Darmstadt
Country [41] 0 0
Germany
State/province [41] 0 0
Dresden
Country [42] 0 0
Germany
State/province [42] 0 0
Düsseldorf
Country [43] 0 0
Germany
State/province [43] 0 0
Eisenach
Country [44] 0 0
Germany
State/province [44] 0 0
Essen
Country [45] 0 0
Germany
State/province [45] 0 0
Frankfurt an der Oder
Country [46] 0 0
Germany
State/province [46] 0 0
Frankfurt
Country [47] 0 0
Germany
State/province [47] 0 0
Freiburg
Country [48] 0 0
Germany
State/province [48] 0 0
Fürth
Country [49] 0 0
Germany
State/province [49] 0 0
Georgsmarienhütte
Country [50] 0 0
Germany
State/province [50] 0 0
Giessen
Country [51] 0 0
Germany
State/province [51] 0 0
Goslar
Country [52] 0 0
Germany
State/province [52] 0 0
Gütersloh
Country [53] 0 0
Germany
State/province [53] 0 0
Halle
Country [54] 0 0
Germany
State/province [54] 0 0
Hamburg
Country [55] 0 0
Germany
State/province [55] 0 0
Hamm
Country [56] 0 0
Germany
State/province [56] 0 0
Hanau
Country [57] 0 0
Germany
State/province [57] 0 0
Hannover
Country [58] 0 0
Germany
State/province [58] 0 0
Herford
Country [59] 0 0
Germany
State/province [59] 0 0
Jena
Country [60] 0 0
Germany
State/province [60] 0 0
Kaiserslautern
Country [61] 0 0
Germany
State/province [61] 0 0
Kassel
Country [62] 0 0
Germany
State/province [62] 0 0
Köln
Country [63] 0 0
Germany
State/province [63] 0 0
Leer
Country [64] 0 0
Germany
State/province [64] 0 0
Leipzig
Country [65] 0 0
Germany
State/province [65] 0 0
Limburg
Country [66] 0 0
Germany
State/province [66] 0 0
Lübeck
Country [67] 0 0
Germany
State/province [67] 0 0
Magdeburg
Country [68] 0 0
Germany
State/province [68] 0 0
Mainz
Country [69] 0 0
Germany
State/province [69] 0 0
Mannheim
Country [70] 0 0
Germany
State/province [70] 0 0
Marburg
Country [71] 0 0
Germany
State/province [71] 0 0
Mayen
Country [72] 0 0
Germany
State/province [72] 0 0
Moers
Country [73] 0 0
Germany
State/province [73] 0 0
Mutlangen
Country [74] 0 0
Germany
State/province [74] 0 0
Mönchengladbach
Country [75] 0 0
Germany
State/province [75] 0 0
Mülheim
Country [76] 0 0
Germany
State/province [76] 0 0
München
Country [77] 0 0
Germany
State/province [77] 0 0
Münster
Country [78] 0 0
Germany
State/province [78] 0 0
Neunkirchen/Saar
Country [79] 0 0
Germany
State/province [79] 0 0
Nürnberg
Country [80] 0 0
Germany
State/province [80] 0 0
Oldenburg
Country [81] 0 0
Germany
State/province [81] 0 0
Osnabrueck
Country [82] 0 0
Germany
State/province [82] 0 0
Paderborn
Country [83] 0 0
Germany
State/province [83] 0 0
Pforzheim
Country [84] 0 0
Germany
State/province [84] 0 0
Pinneberg
Country [85] 0 0
Germany
State/province [85] 0 0
Pirna
Country [86] 0 0
Germany
State/province [86] 0 0
Porta Westfalica
Country [87] 0 0
Germany
State/province [87] 0 0
Pößneck
Country [88] 0 0
Germany
State/province [88] 0 0
Ravensburg
Country [89] 0 0
Germany
State/province [89] 0 0
Recklinghausen
Country [90] 0 0
Germany
State/province [90] 0 0
Regensburg
Country [91] 0 0
Germany
State/province [91] 0 0
Rostock
Country [92] 0 0
Germany
State/province [92] 0 0
Rötha
Country [93] 0 0
Germany
State/province [93] 0 0
Schweinfurt
Country [94] 0 0
Germany
State/province [94] 0 0
Schwäbisch-Hall
Country [95] 0 0
Germany
State/province [95] 0 0
Siegburg
Country [96] 0 0
Germany
State/province [96] 0 0
Stade
Country [97] 0 0
Germany
State/province [97] 0 0
Stendal
Country [98] 0 0
Germany
State/province [98] 0 0
Stuttgart
Country [99] 0 0
Germany
State/province [99] 0 0
Traunstein
Country [100] 0 0
Germany
State/province [100] 0 0
Trier
Country [101] 0 0
Germany
State/province [101] 0 0
Velbert
Country [102] 0 0
Germany
State/province [102] 0 0
Villingen-Schwenningen
Country [103] 0 0
Germany
State/province [103] 0 0
Weilheim
Country [104] 0 0
Germany
State/province [104] 0 0
Wiesbaden
Country [105] 0 0
Germany
State/province [105] 0 0
Wilhelmshaven
Country [106] 0 0
Germany
State/province [106] 0 0
Witten
Country [107] 0 0
Germany
State/province [107] 0 0
Wuerselen
Country [108] 0 0
Germany
State/province [108] 0 0
Zittau
Country [109] 0 0
Germany
State/province [109] 0 0
Zwickau
Country [110] 0 0
Guatemala
State/province [110] 0 0
Guatemala
Country [111] 0 0
Hong Kong
State/province [111] 0 0
Hong Kong
Country [112] 0 0
Hungary
State/province [112] 0 0
Budapest
Country [113] 0 0
Hungary
State/province [113] 0 0
Gyor
Country [114] 0 0
Hungary
State/province [114] 0 0
Gyula
Country [115] 0 0
Hungary
State/province [115] 0 0
Kaposvar
Country [116] 0 0
Hungary
State/province [116] 0 0
Nyíregyháza
Country [117] 0 0
Hungary
State/province [117] 0 0
Szeged
Country [118] 0 0
Hungary
State/province [118] 0 0
Szolnok
Country [119] 0 0
Indonesia
State/province [119] 0 0
Bandung
Country [120] 0 0
Indonesia
State/province [120] 0 0
Jakarta
Country [121] 0 0
Indonesia
State/province [121] 0 0
Jogjakarta
Country [122] 0 0
Indonesia
State/province [122] 0 0
Surabaya
Country [123] 0 0
Italy
State/province [123] 0 0
Calabria
Country [124] 0 0
Italy
State/province [124] 0 0
Emilia-Romagna
Country [125] 0 0
Italy
State/province [125] 0 0
Lazio
Country [126] 0 0
Italy
State/province [126] 0 0
Piemonte
Country [127] 0 0
Italy
State/province [127] 0 0
Puglia
Country [128] 0 0
Italy
State/province [128] 0 0
Sicilia
Country [129] 0 0
Italy
State/province [129] 0 0
Toscana
Country [130] 0 0
Korea, Republic of
State/province [130] 0 0
Busan
Country [131] 0 0
Korea, Republic of
State/province [131] 0 0
Daegu
Country [132] 0 0
Korea, Republic of
State/province [132] 0 0
Seoul
Country [133] 0 0
Malaysia
State/province [133] 0 0
Ampang
Country [134] 0 0
Malaysia
State/province [134] 0 0
Kuala Lumpur
Country [135] 0 0
Malaysia
State/province [135] 0 0
Kuching
Country [136] 0 0
Malaysia
State/province [136] 0 0
Sabah
Country [137] 0 0
Netherlands
State/province [137] 0 0
Amstelveen
Country [138] 0 0
Netherlands
State/province [138] 0 0
Amsterdam
Country [139] 0 0
Netherlands
State/province [139] 0 0
Apeldoorn
Country [140] 0 0
Netherlands
State/province [140] 0 0
Beverwijk
Country [141] 0 0
Netherlands
State/province [141] 0 0
Capelle Aan De Yssel
Country [142] 0 0
Netherlands
State/province [142] 0 0
Delftzijl
Country [143] 0 0
Netherlands
State/province [143] 0 0
Den Haag
Country [144] 0 0
Netherlands
State/province [144] 0 0
Eindhoven
Country [145] 0 0
Netherlands
State/province [145] 0 0
Goes
Country [146] 0 0
Netherlands
State/province [146] 0 0
Leidschendam
Country [147] 0 0
Netherlands
State/province [147] 0 0
Rotterdam
Country [148] 0 0
Netherlands
State/province [148] 0 0
Tilburg
Country [149] 0 0
Netherlands
State/province [149] 0 0
Utrecht
Country [150] 0 0
New Zealand
State/province [150] 0 0
Auckland
Country [151] 0 0
Panama
State/province [151] 0 0
Panama City
Country [152] 0 0
Panama
State/province [152] 0 0
Panama
Country [153] 0 0
Peru
State/province [153] 0 0
Arequipa
Country [154] 0 0
Peru
State/province [154] 0 0
Cusco
Country [155] 0 0
Peru
State/province [155] 0 0
La Victoria, Lima
Country [156] 0 0
Philippines
State/province [156] 0 0
Cebu City
Country [157] 0 0
Philippines
State/province [157] 0 0
Manila
Country [158] 0 0
Philippines
State/province [158] 0 0
Quezon City
Country [159] 0 0
Portugal
State/province [159] 0 0
Lisboa
Country [160] 0 0
Portugal
State/province [160] 0 0
Matosinhos
Country [161] 0 0
Portugal
State/province [161] 0 0
Ponta Delgada
Country [162] 0 0
Portugal
State/province [162] 0 0
Setubal
Country [163] 0 0
Portugal
State/province [163] 0 0
Viseu
Country [164] 0 0
Romania
State/province [164] 0 0
Baia Mare
Country [165] 0 0
Romania
State/province [165] 0 0
Brasov
Country [166] 0 0
Romania
State/province [166] 0 0
Bucharest
Country [167] 0 0
Romania
State/province [167] 0 0
Bucuresti
Country [168] 0 0
Romania
State/province [168] 0 0
Cluj-Napoca
Country [169] 0 0
Romania
State/province [169] 0 0
Craiova
Country [170] 0 0
Romania
State/province [170] 0 0
Iasi
Country [171] 0 0
Romania
State/province [171] 0 0
Sibiu
Country [172] 0 0
Romania
State/province [172] 0 0
Timisoara
Country [173] 0 0
Sweden
State/province [173] 0 0
Falun
Country [174] 0 0
Sweden
State/province [174] 0 0
Göteborg
Country [175] 0 0
Sweden
State/province [175] 0 0
Jönköping
Country [176] 0 0
Sweden
State/province [176] 0 0
Karlstad
Country [177] 0 0
Sweden
State/province [177] 0 0
Sundsvall
Country [178] 0 0
Sweden
State/province [178] 0 0
Västerås
Country [179] 0 0
Taiwan
State/province [179] 0 0
Kaohsung
Country [180] 0 0
Taiwan
State/province [180] 0 0
Taichung
Country [181] 0 0
Taiwan
State/province [181] 0 0
Taipei
Country [182] 0 0
Thailand
State/province [182] 0 0
Bangkok
Country [183] 0 0
Thailand
State/province [183] 0 0
Chiang Mai
Country [184] 0 0
Thailand
State/province [184] 0 0
Khon Kaen
Country [185] 0 0
Turkey
State/province [185] 0 0
Ankara
Country [186] 0 0
Turkey
State/province [186] 0 0
Denizli
Country [187] 0 0
Turkey
State/province [187] 0 0
Erzurum
Country [188] 0 0
Turkey
State/province [188] 0 0
Malatya
Country [189] 0 0
Vietnam
State/province [189] 0 0
Ha Noi
Country [190] 0 0
Vietnam
State/province [190] 0 0
Hochiminh city

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This multi-center, open-label, randomized study will evaluate the participant preference with
subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in
participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's
lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV)
on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4,
followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive
MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8
cycles of standard chemotherapy (according to local country practice) with 8 cycles of
MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01724021
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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/ct2/show/NCT01724021